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Wednesday, December 5, 2018

LINX Procedure Information for GERD

I stumbled upon this for other research I am also doing right now and thought I would write about it, because it seemed interesting to me, and that maybe it might help those who are dealing with truly horrible acid reflux. As I just said, I stumbled onto this subject but I was not really sure what the Linx System did until I read about it for this article. So, please excuse all of the block quotes. I do that when I'm not familiar with a subject and I am learning about it as I go, but I want to make sure I give you the correct information, because that's the most important, especially if it might help you in some way.


***There was a RECALL notice for certain devices as of May 2018.***

The information for it can be found here: RECALL NOTICE: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163588


The FDA approved the LINX method in 2012, according to the documents below,


Source: http://www.toraxmedical.com/news/downloads/PR_LINXFDAApproval.pdf




I am not familiar with this medical equipment or procedure yet, so I wanted to research it for those of you out there who may not have heard of it yet, as it might help you. According to Healio Gastroenterology,

"LINX Reflux Management
Give Us a Call
For more information about LINX reflux management at MUSC,
call: Mary Johnson, RN
(843) 876-3090 or
johnsome@musc.edu

A patient suffering with gastroesophageal reflux disease (GERD) normally experiences frequent heartburn, regurgitation and/or nausea in the mid-chest region. This can cause severe discomfort and negatively impact the patient's quality of daily life.

If you are a reflux patient, 21 years of age or older, who still experiences significant GERD-related symptoms despite taking medication(s), you may be interested in the LINX® Reflux Management System.

LINX provides an option for patients who are taking acid-suppressing drugs (i.e. Prevacid®, Nexium®, Prilosec®, etc.) but are not getting their desired results. These types of medications help control acid build-up, but they cannot repair the underlying problem.

A color illustration of the lower esophagus and upper stomach showing placement of a small band of magnetized titanium beads wrapped around the lower esophageal sphincter.


What is LINX?

The LINX Reflux Management System (developed by Torax Medical, Inc.) is a permanent, drug-free treatment for GERD that consists of a small band of magnetized titanium beads wrapped around the lower esophageal sphincter (LES) located at the base of the esophagus. This band helps prevent gastric acids from pushing back up into the esophagus from the stomach, yet also safely allows the LES to open when required to allow for easy swallowing.

When a person with the LINX system installed swallows, the motion of food or drink passing through the lower esophagus overcomes the magnetic attraction between the beads permitting the contents to pass through the LES into the stomach. When the stomach reacts and reflux tries to escape up the esophagus (which would then result in heartburn), the magnetic beads keep the acid down in the same manner as a normally functioning LES.

This procedure can help patients return to a normal lifestyle unaffected by their GERD."






Source:http://ddc.musc.edu/public/surgery/laparoscopic/linx.html





Source:http://ddc.musc.edu/public/surgery/laparoscopic/linx.html




According to RefluxMD,

"Ten things you need to know about LINX
By Dr. Dengler
Last updated on November 15th, 2018 at 02:23 pm
This Article is Written and/or Reviewed by RefluxMD Medical Authors Team and Reviewers






One out of three Americans suffer from heartburn symptoms. Many of those sufferers have gastroesophageal reflux disease (GERD) and they don’t even know it.

Until recently the only cure was a surgical procedure known as 'Nissen fundoplication,' which has the potential to cause side effects that lead many to delay or avoid surgery. Last year, the Food and Drug Administration approved a new treatment device called the LINX Reflux Management System to offer a new approach to treating GERD, a disease that is increasing at a rate of 30 percent every decade.

Paul Taiganides, M.D., is the medical director of the Knox Regional Heartburn Treatment Center at Knox Community Hospital in Mount Vernon, Ohio. Dr. Taiganides and Knox Community Hospital were one of 14 locations selected to participate in the initial US clinical trials for the LINX device. Since then, Dr. Taiganides has performed more LINX procedures than any other U.S. surgeon. The center has done more than 700 Nissen fundoplication surgical procedures in the last seven years. Recently, he has trained surgeons in the LINX technique at Harvard University and Northwestern University.

'I was recommended to the LINX by Tom DeMeester [M.D.] and William Dengler [M.D.], medical advisors to RefluxMD. Dr. DeMeester is the recognized global leader on reflux disease and a senior medical advisor to Torax Medical, the innovator behind the LINX System,' said Dr. Taiganides. 'This is the first advancement in the surgical treatment of GERD in 50 years — and I believe this small titanium band will have a huge impact on how we surgically treat reflux disease.'


Here are 10 things you need to know about the LINX procedure.

No. 1: It is focused on the underlying cause of reflux disease not the side effect.
Reflux disease is a result of a damaged lower esophageal sphincter (LES). The LES is a muscle that is constantly closed, but allows food and liquid to pass into the stomach. When the LES loses its strength, acidic stomach juices can back up into the esophagus creating the painful symptom of heartburn. The LINX device wraps around the LES, augmenting it to prevent reflux.

No. 2: It is safer than the long-term use of proton pump inhibitors (PPIs).
PPIs only treat symptoms. More importantly, studies have proven that reflux disease can progress even when PPI therapy has effectively eliminated GERD symptoms. Furthermore, daily PPI use has been associated with Barrett’s Esophagus, a pre-cancerous condition, an increase in bone fractures, a higher risk of pneumonia, an increased incidence of C. difficile intestinal infections, and increased risk of heart arrhythmias.

No. 3: LINX is effective at reducing symptoms and improving quality of life.
A recent study published in the New England Journal of Medicine tracked 100 patients for three years after their LINX surgery. That study found an overall decrease in stomach contents reaching the esophagus, fewer reflux symptoms, and a substantial reduction in PPI usage.

No. 4: The side effects disappear over time in most cases.
Initially, most patients experience some discomfort, but it typically dissipates over several weeks. In addition, the most commonly reported side effect is mild difficulty swallowing, which usually subsides over time.

No. 5: The cost of the device is approximately $5,000.
Surgery costs between $12,000 and $20,000. A traditional Nissen fundoplication surgical procedure is estimated in excess of $18,000. The cost can be much less than a lifetime of PPI use: a 2010 study by Consumer Reports found once-a-day PPI use can range from $2,000 to $4,500 per year for brand name prescription PPIs.

No. 6: There are very few physicians performing the LINX procedure.
Like all surgical procedures, a surgeon’s proficiency is largely dependent upon the number of procedures performed each year. Torax Medical has been very selective in choosing their surgeons seeking the most experienced physicians available.

No. 7: This is minimally invasive and is performed as an out-patient procedure.
The LINX procedure is usually completed in less than one hour. After the use of general anesthesia, small surgical instruments and a video camera are used in this laparoscopic procedure. Within 24 hours most patients return to a normal diet although there is some difficulty getting used to a functioning LES. These difficulties typically subside in 10 to 15 days and most patients report no symptoms after two or three months.

No. 8: LINX is reversible and can be replaced.
Since the LINX band is placed around the LES, the device can be removed or replaced, if necessary. This requires a surgical procedure, and Dr. Taiganides noted that this has not been necessary for any of his patients.

No. 9: This procedure is recommended for those with continued GERD symptoms under maximum therapy prescribed by a specialist.
I agree with Dr. DeMeester that a reflux disease has defined stages. Early stages must be treated with diet and lifestyle changes along with intermittent drug therapy. When these therapies fail to manage GERD symptoms impacting daily activities or sleep, the LINX System should be considered as an option.

No. 10: LINX is not for everyone with advanced GERD.
Today LINX is not approved for those with Barrett’s Esophagus or anyone suffering from esophageal cancer. It is important for everyone suffering from advanced stages of reflux disease to explore all available options before their disease progresses to the point where options are limited.

It is important to take your heartburn symptoms seriously because it is a signal from your body that something is wrong. Since reflux disease is a progressive chronic condition, you need to make the necessary changes before you have to schedule a surgery."





Source:https://www.laparoscopyhospital.com/linx-procedure-faq.html




Business Wire says,

"Torax Medical Announces FDA Approval of a New LINX® Device Compatible with 1.5 Tesla Magnetic Resonance Imaging (MRI) Systems

New LINX Device expands patients’ diagnostic imaging options after treatment

ST. PAUL, Minn.--(BUSINESS WIRE)--Torax Medical, Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a next generation LINX® Reflux Management System that is MR conditional in magnetic resonance imaging (MRI) systems up to 1.5 Tesla (1.5T), which represents about 90% of MRI systems in use in the U.S. The LINX 1.5T design contains a different grade of magnets that have a higher resistance to being demagnetized when subjected to external magnetic fields (i.e. MRI).

'We are pleased to make this next generation LINX device available to patients seeking relief from their reflux symptoms while broadening their access to diagnostic imaging options after treatment,' said Todd Berg, President and CEO of Torax Medical.

Patients considering the LINX procedure should consult their healthcare provider regarding any questions related to MR imaging. Patients who have already received a LINX implant should consult their provider prior to undergoing any MRI tests. Information on diagnostic imaging options with LINX is also available at www.linxforlife.com and www.toraxmedical.com.



The Disease

Gastro-esophageal Reflux Disease (GERD) is a chronic, often progressive disease resulting from a weak lower esophageal sphincter that allows harmful gastric fluid to reflux into the esophagus, resulting in both pain and injury to the esophageal lining. GERD is associated with a pre-cancerous condition known as Barrett’s esophagus, which increases the risk of esophageal cancer. Symptoms of GERD include heartburn and regurgitation, often associated with chronic sleep disruption, and may also include persistent cough, excessive throat clearing, hoarseness and a feeling of a “lump” in the throat. Acid reflux medications, such as Prevacid®, Nexium®, and Prilosec®, affect gastric acid production, but do not repair the sphincter defect, allowing continued reflux. The FDA has issued a series of statements on possible side effects of long-term PPI use including: possible fracture risk, low magnesium levels, and clostridium difficile-associated diarrhea. More recently, a study out of Stanford University published in the journal PLOS ONE showed PPI use may increase the risk of heart attack.1 The alternative surgical option to LINX is Nissen fundoplication. Nissen fundoplication reconstructs a new reflux barrier using a portion of the patient’s stomach, which is wrapped around the lower portion of the esophagus.



The LINX Reflux Management System

LINX is a small implant comprised of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the existing esophageal sphincter’s barrier function to prevent reflux. The device is implanted using a standard minimally invasive laparoscopic procedure and is an alternative to the more anatomically disruptive fundoplication, commonly used in surgical anti-reflux procedures. The LINX Reflux Management System is indicated for those patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.

LINX does require a surgical procedure and is associated with potential risks, contraindications and life style modifications. For more information on LINX, including a statement of risks, please visit www.linxforlife.com.



About Torax Medical

Torax Medical, Inc. is a privately-held medical device company headquartered in St. Paul, Minnesota that develops and markets products designed to treat sphincter disorders utilizing its technology platform, Magnetic Sphincter Augmentation (MSA). Torax Medical is currently marketing the LINX® Reflux Management System for the treatment of GERD in the U.S. and Europe and the FENIX® Continence Restoration System for the treatment of Fecal Incontinence (FI) in Europe. For more information, please visit www.toraxmedical.com.

1PLOS ONE DOI:10.1371/journal.pone.0124653

Contacts
Torax Medical, Inc.
Maggie Wallner, 651-361-8900
info@toraxmedical.com"






Source: https://www.swedish.org/blog/2012/05/a-new-treatment-for-gerd-the-linx-reflux-management-system







According to Sages the company who was in charge of the study,




"LINX® REFLUX MANAGEMENT SYSTEM
March 13, 2017 by SAGES Webmaster

SAGES Technology and Value Assessment Committee (TAVAC) Safety and Effectiveness Analysis
LINX® Reflux Management System (Torax Medical, Inc.)

SAGES LINX® Safety and Effectiveness Analysis Committee

Dana Telem, MD, MPH
Andrew Wright, MD
Paresh Shah, MD
TAVAC Committee Chair: Matthew Hutter, MD, MPH



About this update

The original SAGES LINX Safety and Efficacy Analysis (SEA) was completed and published online in 2013. The literature presented in this first document was based on the pre-market and the initial post-market experience that had been published in the peer reviewed literature at the time. In the 3 years that have passed since the original SAGES Technology and Value Assessment Committee (TAVAC) LINX SEA was published, sufficient new data has become available to necessitate an update and a fresh look at the SAGES recommendations with regards to this technology.



Technology Overview

The LINX® Reflux Management System (Torax Medical, Inc., Shoreview, MN, USA) is comprised of a small expandable ring of linked magnetic beads. The device is laparoscopically implanted around the esophagus at the esophagogastric junction to mechanically augment the function of the lower esophageal sphincter (LES) for the treatment of gastroesophageal reflux disease (GERD).

Each bead in the LINX device contains a neodymium iron boron magnetic core coated with biocompatible titanium. Sliding titanium wires connect each bead so that they can move independently, but they can’t completely separate. At rest, each bead is in contact with adjacent beads, minimizing compressive forces upon the esophagus. The magnetic attractive forces between each bead augment the pressure of the LES. At higher pressures, the magnetic forces are overcome and the ring expands to allow esophageal distention and the passage of a swallowed bolus or other physiologic functions, such as belching or vomiting.

The LINX Reflux Management System is based on the premise that a device placed around the LES can assist, or augment, an incompetent LES to maintain a closed position when challenged by gastric reflux. The LINX System is indicated for patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite medical therapy for the treatment of reflux.

The LINX device implantation is performed laparoscopically under general anesthesia. The procedure uses standard laparoscopic ports, instruments and techniques. The device is placed at the end of the esophagus. Minimal dissection is required. A specialized sizing tool is used to measure the external esophageal circumference in the target area – allowing the surgeon to select the appropriately sized LINX device. An uncomplicated procedure can generally be performed in well under 1 hour. In contrast to fundoplication, patients are started on a solid diet soon after the procedure.

The LINX System is not intended for use in patients with suspected or known allergies to metals such as iron, nickel, titanium, or stainless steel. The immediate post-approval version of the LINX device was only compatible with a magnetic resonance imaging device (MRI) up to 0.7T (Tesla). In June of 2015, the FDA approved the next generation of the device compatible and safe with an MRI up to 1.5 Tesla. The LINX System is contraindicated in patients receiving electrical implants such as defibrillators or pacemakers or undergoing insertion of metallic implants in the abdomen.

Development of the LINX device began in 2002. Animal testing of the current device began in 2005 [1]. An FDA approved Investigational Device Exemption (IDE) feasibility trial (#G060172) enrolled 44 patients at 4 sites in the US and Europe in 2007-2008. A 100 patient pivotal trial was subsequently performed at 14 US and European sites. Enrollment occurred throughout 2008-2009. Through 2011, 2-year follow-up on the pivotal trial was available. An FDA expert panel considered the clinical data from these 2 trials in January 2012, and pre-market approval (PMA #P100049) was granted in March 2012 [2].

FDA Instructions for Use (2012)
Indications
The LINX system is labeled for use in GERD patients with abnormal pH testing who continue to have chronic symptoms despite anti-reflux therapy.



Precautions (summary)
The LINX device has not been evaluated in patients with a hiatal hernia larger than 3-cm. Use of LINX device in patients with a hiatal hernia larger than 3-cm should be considered on the basis of each patient’s medical history and severity of symptoms.
The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett’s esophagus or Grade C or D (LA classification) esophagitis.
The safety and effectiveness of the LINX device has not been evaluated in patients with major motility disorders.
The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:
Scleroderma
Suspected or confirmed esophageal or gastric cancer
Prior esophageal or gastric surgery or endoscopic intervention
Distal esophageal motility less than 35-mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or a known motility disorder (such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES). Symptoms of dysphagia more than once per week within the last 3 months. Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.). Esophageal or gastric varices. Morbid obesity (BMI >35).
Age <21 1. Technology Significance Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disease in the United States. It is also one of the most important in terms of its chronicity, overall cost, adverse impact on quality of life, and potential for complications, such as Barrett’s esophagus and esophageal adenocarcinoma [3]. Current estimates suggest that GERD affects around 10–20% of adults in Western countries on a daily or weekly basis [4]. Up to 50% of patients with GERD may require chronic pharmacologic therapy [5]. Long term GERD pharmacotherapy is exceedingly expensive with an estimated annual cost in the US of $11 billion [6]. The most powerful and commonly prescribed acid suppression medications are proton pump inhibitors (PPIs). PPIs have been linked via retrospective studies to increased risk of enteric infections including Clostridium difficile-associated diarrhea, community-acquired pneumonia, bone fracture, nutritional deficiencies, and interference with metabolism of antiplatelet agents [7]. It is estimated that as many as 40% of patients with GERD fail to respond symptomatically to aggressive acid suppression therapy [8,9,10]. As a result, 20-40% of patients are dissatisfied with medical GERD treatment and see no viable alternative to more medications and persistent symptoms [11]. Some patients with severe GERD and associated complications undergo antireflux surgery. Despite the fact that the prevalence of GERD has increased in recent years, utilization of laparoscopic Nissen fundoplication for medically refractory GERD has declined. With literally millions of American adults continuing to suffer from GERD symptoms despite aggressive medical therapy, an estimated 24,000 Americans underwent laparoscopic Nissen fundoplication in 2003 [12]. This accounts for less than 1% of patients estimated to be dissatisfied or who suffer from persistent symptoms on acid suppression medical therapy. This discrepancy is thought to be at least partly due to concerns over side effects associated with Nissen fundoplication (dysphagia, bloating) as well as the possibility of fundoplication failure with recurrent GERD and need for acid suppression medical therapy or repeat surgery. Patients with GERD who have persistent symptoms on medical therapy who aren’t willing to consider traditional antireflux surgery (or are not referred to a surgeon to be considered) fall into what is known as the GERD treatment gap. The LINX system may be an attractive alternative to chronic medical therapy for GERD patients who are hesitant to undergo Nissen fundoplication. Following fundoplication, some patients describe difficulty belching and symptoms of bloating [13,14]. Data from the premarket trial suggests that following the LINX procedure; most patients maintain their ability to belch and frequent/continuous bloating was reported at a low rate (5% of patients 12 months following LINX implantation described frequent or continuous bloating compared to 40% at baseline) [2]. Augmentation of the esophageal sphincter with a magnetic device may provide an alternative treatment for patients with incomplete symptom relief on acid suppression medical therapy or who are reluctant to undergo surgical fundoplication.
The size differences between the Linx and a quarter
Source:https://fox4kc.com/sponsored/?prx_t=eK4CArO4NArSEKA&prx_ro=s




2. Current Clinical Practice and Alternatives

Mild to moderate cases of GERD are typically treated with lifestyle modifications, over-the-counter medications, and prescription drugs. Lifestyle changes include weight loss, avoiding certain foods, managing meal size and timing, and elevating the head of the bed. Continuous pharmacotherapy is a mainstay of GERD treatment. PPIs work by suppressing stomach acid production and subsequent reflux acidity. PPIs do not address the mechanism of regurgitation in patients with pathologic GERD. Central to the pathogenesis of GERD is a weak or incompetent LES that opens abnormally and allows the reflux of gastric contents into the esophagus.

In normal subjects, omeprazole treatment does not affect the number of reflux episodes or their duration; rather it converts acid reflux to less acid reflux, thus exposing esophagus to altered gastric juice. These observations may explain the persistence of symptoms and emergence of mucosal injury while on proton pump inhibitor therapy [15]. Limitations of PPIs include the need for daily use, high cumulative costs, and decreased efficacy over time.

Surgical procedures are typically considered in patients with symptoms despite optimal PPI therapy and in patients with severe GERD. Surgery is used, however in less than 1% of eligible GERD patients, and its usage has been decreasing over the last decade [16]. Laparoscopic fundoplication is the most commonly performed antireflux operation. The laparoscopic approach to fundoplication was introduced and popularized in the 1990’s. The surgical technique involves a complete hiatal dissection with mobilization of the esophagus and fundus, re-approximation of the diaphragmatic crura, and creation of a 360-degree wrap of fundus around the distal esophagus. Laparoscopic Nissen fundoplication can be accomplished in 2 hours or less for uncomplicated cases. Most patients stay in the hospital for 1-2 days. Many surgeons have their patients gradually transition from a soft or pureed diet to a more solid diet over the course of 2-8 weeks [17]. Relief of symptoms, especially esophageal symptoms such as heartburn and regurgitation occurs in > 90% of patients and has been demonstrated to be durable beyond 10 years for the majority of patients [18,19]. Potential surgical side effects following Nissen fundoplication include difficulty swallowing, increased flatus, bloating, early satiety, and inability to vomit or belch [20,21]. Anatomic failure of the fundoplication with recurrent GERD can occur in 2-17% of cases [22].


Source:http://pediatricfeeding.com/fundoplication/



The published outcomes of antireflux surgery are not always replicated in the community, especially for surgeons who perform laparoscopic antireflux surgery infrequently [23,24]. SAGES has published a Guidelines for Surgical Treatment of Gastroesophageal Reflux Disease. According to this document “The standardization of antireflux surgery technique is highly desirable, as it has been shown to lead to good postoperative patient outcomes (Grade A). Like any other surgical procedure, laparoscopic antireflux surgery is subject to a learning curve, which may impact patient outcomes. Therefore, surgeons with little experience in advanced laparoscopic techniques and fundoplication in particular should have expert supervision during their early experience with the procedure to minimize morbidity and improve patient outcomes (Grade B).” [25] Concerns related to potential side effects, recurrent GERD, and repeat surgery following laparoscopic Nissen fundoplication likely play a role in the fact that most patients who meet indications for antireflux surgery never undergo this procedure.

As an alternative to laparoscopic antireflux surgery, there are other commercially available, FDA approved endoscopic incisionless procedures designed to treat GERD. An exhaustive review of these technologies is outside of the scope of this document. A 2013 SAGES Statement on Endoluminal Treatments for GERD focused on 2 endoluminal devices available at the time of the review – EsophyX (Trans Oral Fundoplication or TIF, Endogastric Solutions, Redmond, WA) and Stretta (Mederi Therapeutics, Norwalk, CT) and is available for review. [26]. Direct comparisons between LINX and other commercially available products are unavailable. Experience with endoluminal GERD treatments continues to evolve.




Source:http://surgicalinstitute.com/nissen-fundoplication.html






3. Clinical Evidence Summary

Clinical studies involving the LINX system were identified via a search of the PubMed/Medline database (www.ncbi.nlm.nih.gov/pubmed) conducted in July 2016. The literature search used combinations of the keywords LINX, reflux, magnetic, magnetic sphincter augmentation, and/or GERD. Review articles without unique clinical data were excluded. Articles pertaining to the use of LINX in patients who have previously undergone bariatric surgery were considered outside the scope of this review and excluded. The bibliographies of key references were searched for relevant studies not uncovered in the PubMed search. The manufacturer’s website was also used to identify key references. Finally, summary reports for unpublished clinical data used in the approval process were identified on the FDA Web site. Patients from the feasibility and the pivotal trial are included in many other case series and case-control series. Patients from the post-market experience at numerous centers are represented several times in more recent publications included in this updated review. All references are described in detail in Appendix A.





4. Safety and Efficacy Data


Summary Paragraph:
Review of published studies suggests that magnetic sphincter augmentation is safe with no reported deaths and a 0.1% rate of intra/perioperative complications [27]. Long-term efficacy of LINX appears good for typical GERD symptoms with reduced acid exposure, improved GERD symptoms, and freedom from PPI in 85-88% at 3-5 years [28,29,30]. The most common side effect is dysphagia, the rate of which likely differs based on definition and patient population. Early dysphagia within the first few weeks is common at about 70% [31,32]. Dysphagia resolves in most patients and the incidence is roughly 10% at 1 year and 4% at 3 years [31]. The need for endoscopic dilation ranges from 6-12% [27, 33] and the primary reason for explantation appears to be persistent dysphagia with a rate in larger series from 3-6% [27,28,31]. Erosion appear to be rare, with one case reported in the 1st 1,000 patients [27], one additional published case report [34], a large series reporting 2 erosions [35], and several additional reports in the FDA MAUDE dataset (true number unknown, as multiple entries in this dataset may be made for each patient). Based on very limited literature, erosion can be successfully treated with explantation. Initially there were concerns about safety of LINX in patients who might later need an MRI. Patients who underwent LINX implantation prior to May 2015 are limited to MRI under 0.7T, while patients who have LINX subsequent to that date may have MRIs up to 1.5T (Torax website).



Publication Review
The literature search found reports on 2 FDA-approved IDE clinical studies. The initial feasibility study was a prospective, multi-center, non-randomized case series that enrolled 44 patients between February 2007 and October 2008 at 4 sites in the US and Europe (11 LINX procedures performed in the US and 33 in Europe). Four separate publications report results at 3-months [36],1 to 2 years [37], 4 years [38], and 5 years [30]. The pivotal study was a prospective, non-randomized, multi-center clinical trial enrolling 100 patients (96 US and 4 European) at 14 sites (13 US and 1 European). Data from 2-year follow-up were presented in FDA documents as part of the pre-market approval process [2]. Three-year follow-up on the pivotal trial was published at the time of the first version of this document [31]. More recently, 5-year follow-up on the pivotal study cohort was published as well [29].

Bonavina et al. [36] conducted a multicenter feasibility trial to evaluate safety and efficacy of the “magnetic sphincter augmentation device.” Patients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia >3 cm were excluded from the study. Over a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97%of patients were discharged within 48 h. The mean follow-up was 209 days (range 12–434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p<0.005). At 3 months postoperatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred. From this study, the authors suggest that in their experience laparoscopic implantation of the magnetic sphincter augmentation device is safe and well tolerated. They also propose that the short learning curve and minimal dissection required may be advantageous. Bonavina et al. [37] later conducted a 1 and 2-year evaluation of the above feasibility trial. At baseline, all 44 patients had abnormal esophageal acid exposure on 24-hour pH monitoring and improved, but persistent, typical GERD symptoms while on acid suppression therapy with PPIs. Patients were evaluated after surgery by GERD Health-Related Quality of Life symptom score, PPI usage, endoscopy, esophageal manometry, and 24-hour esophageal pH monitoring. The total mean GERD Health-Related Quality of Life symptom scores improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1 and 2-year follow-up, representing an 85% and 90% reduction, respectively (P < 0.0001). Complete cessation of PPI use was reported by 90% of patients at 1 year and by 86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and self-resolved by 90 days. One device was laparoscopically explanted for persistent dysphagia without disruption of the anatomy or function of the cardia. There were no device migrations, erosions, or induced mucosal injuries. At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. The mean percentage time pH was less than 4 decreased from a baseline of 11.9% to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. Patient satisfaction was 87% at 1 year and 86% at 2 years. The authors conclude, “The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up.” Lipham et al. [38] followed this same patient cohort and evaluated these 44 patients at 3 and 4 years. Each patient’s baseline GERD status served as the control for evaluations post implant. For esophageal acid exposure, the mean total % time pH < 4 was reduced from 11.9 % at baseline to 3.8 % at 3 years, with 80 % of patients achieving pH normalization. At ≥4 years, 100 % of the patients had improved quality-of-life measures for GERD, and 80 % had complete cessation of the use of proton pump inhibitors (PPIs). There have been no reports of long-term device-related complications such as migration or erosion. The authors concluded that, “Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation.” Saino et al recently reported the 5-year outcomes of the feasibility trial cohort [30]. Of the original 44 patients, 33 were available for follow-up at 5-years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the longer term, including no device erosions or migrations. The authors conclude that based on long-term reduction in esophageal acid, symptom improvement, and no late complications, that they have demonstrated the relative safety and efficacy of magnetic sphincter augmentation for GERD. In the FDA Summary of Safety and Effectiveness Data (SSED) document, with regards to safety, the FDA concludes: “The safety of the LINX Reflux Management System in the treatment of subjects with GERD was based on adverse event data from 100 subjects followed for up to 24 months. The 12-month data demonstrated 162 total adverse events reported in 76% of the subjects. Most adverse events resolved without sequelae. Dysphagia was the most common adverse event with 76 events being reported in 68% of the subjects, with 11% of the subjects reporting ongoing dysphagia. Eighteen (18) subjects underwent esophageal dilatation and 10 continued to have dysphagia at 24 months. Furthermore, there were several subjects who experienced symptoms of odynophagia/dysphagia that started after 180 days (182-605) and several subjects who had odynophagia and/or dysphagia that took over 180 days to resolve (maximum time noted 447 days). Overall, the incidence of dysphagia was found to be comparable to the incidence of dysphagia that is reported in patients undergoing anti-reflux surgery, such as Nissen fundoplication. Overall, the safety data from the pivotal trial supports a reasonable assurance that the LINX device is safe.”
Source: https://fox4kc.com/sponsored/?prx_t=eK4CArO4NArSEKA&prx_ro=s





With regards to effectiveness, based on the pivotal trial data the FDA concludes: “While the success criterion for the pre-specified primary objective of the study (pH normalization or a ≥ 50% reduction in distal esophageal acid exposure) was not met, there was improvement in esophageal pH. Sixty four of 100 subjects met the primary endpoint; there were 56 subjects who had normalization of pH and another 8 subjects who had a least a 50% reduction in total time that the pH < 4, however the lower limit of the 97.5% confidence interval was only 53.8% instead of the pre-specified 60%. Even more subjects had success in meeting the secondary objectives of improvement in GERD symptoms and reduction in PPI usage. The success rate for reduction in GERD symptoms was 92% at 12 months and 84% at 24 months. Similarly, reduction of at least 50% in PPI use was seen in 93% of subjects at 12 months and 86% at 24 months. The majority of these subjects, 88 at 12 months and 83 at 24 months, eliminated their use of PPIs. Although the primary objective of the study was not met, FDA considered the improvement in esophageal pH that was seen in 64% of subjects in addition to the improvement in GERD symptoms and reduction in PPI medication use demonstrated a reasonable assurance as to the effectiveness of the LINX Reflux Management System.” Ganz et al. [31] published 3-year follow-up data on the 100 patients enrolled in the pivotal trial. With regards to safety, “serious adverse events occurred in six patients and required removal of the device in four of the six. In three of the patients, the device was removed at 21, 31, and 93 days after implantation because of persistent dysphagia, with resolution in all three patients after removal, and in one patient, the device was removed at 357 days owing to intermittent vomiting of unknown cause starting 3 months after implantation, without relief after removal.” The most frequent adverse event was dysphagia, which occurred in 68% of patients postoperatively. Ongoing dysphagia was noted in 11% of patients at 1 year, in 5% at 2 years, and in 4% at 3 years. Esophageal dilation for dysphagia was allowed at the discretion of the investigator. A total of 19 patients underwent dilation, with 16 reporting improvement after the procedure. Chest radiography and endoscopy performed at 1 year and at 2 years after implantation showed no evidence of device migration or erosion. At 3 years, 2 patients reported an inability to belch or vomit. With regards to safety, the authors concluded, “Studies with larger samples and longer term follow-up are needed to confirm these early results and assess longer-term safety.” With regards to effectiveness, these investigators determined that normalization of or at least a 50% reduction in esophageal acid exposure was achieved in 64% of patients (64 of 100; 95% confidence interval [CI], 54 to 73). The secondary efficacy end point, a 50% reduction in the quality of life score, as compared with the score without proton-pump inhibitors at baseline, was achieved in 92% of patients (92 of 100; 95% CI, 85 to 97). A reduction of 50% or more in the average daily dose of proton-pump inhibitors occurred in 93% of patients (93 of 100 patients; 95% CI, 86 to 97). With regards to effectiveness, the authors concluded that the magnetic device decreased exposure to esophageal acid, improved reflux symptoms, and allowed cessation of proton-pump inhibitors in the majority of patients. Ganz and colleagues later reported the 5-year outcomes for 85 of the 100 patients enrolled in the pivotal trial [29]. Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking proton pump inhibitors, and 11 in patients on these medications. Five years after device placement this score decreased to 4. All patients used proton pump inhibitor medications at baseline and at 5 years these medications were only used in 15%. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. The authors conclude that augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. Additional notable recent additions to the literature include a safety analysis of the first 1,000 patients implanted with a device [27]. Event rates were 0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations. All reoperations were performed non-emergently for device removal, with no complications or conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The authors of this study concluded that with regards to safety, the overall event rates were low based on data from 82 institutions, and that the LINX device is a safe therapeutic option. Asti et al. [35] reported the results of a retrospective review of prospectively collected data examining the outcomes of 164 patients undergoing LINX implantation with median follow-up of 48 months. In eleven patients (6.7%), the device was ultimately removed for heartburn or regurgitation (n=5), dysphagia (n=4), or chest pain (n=2). In 2 patients, full-thickness erosion of the esophageal wall with partial endoluminal penetration of the device occurred. The estimated removal-free probability at 80 months was 0.91 [confidence interval (CI) 0.86–0.96]. The median implant duration was 20 months, with 82% of the patients being explanted between 12 and 24 months after the implant. Device removal was most commonly combined with partial fundoplication. There were no conversions to laparotomy and the postoperative course was uneventful in all patients. These authors conclude that laparoscopic removal of the LINX device “can be safely performed as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion.”
Source: https://www.urmc.rochester.edu/surgery/thoracic/linx.aspx





There are several publications comparing clinical outcomes of the LINX device when compared to laparoscopic Nissen fundoplication. Louie et al. [39] compared perioperative outcomes, symptom control, side effects, adverse events, and pH studies in 34 consecutive patients who underwent LINX to 32 consecutive patients who had laparoscopic Nissen fundoplication. All patients with a hiatal hernia > 3-cm were excluded from this analysis. Operative time was longer for fundoplication. At 6 months, scores on the Gastroesophageal Reflux Disease Health Related Quality of Life scale improved from 20.6 to 5.0 for LINX vs. 22.8 to 5.1 for fundoplication. Postoperative DeMeester scores (14.2 vs. 5.1, p=0.0001) and the percentage of time pH was less than 4 (4.6 vs. 1.1; p=0.0001) were normalized in both groups. , but lower in the LINX group. LINX resulted in improved gas and bloat sensations (1.32 vs. 2.36; p=0.59) and enabled belching in 67% compared with none of the fundoplication patients. The investigators determined that LINX results in similar GERD symptom control with an improved quality of life compared to fundoplication.

Sheu et. al. [40] compared the outcomes of 12 patients to undergo LINX to 12 patients who had undergone laparoscopic Nissen fundoplication who were matched based on age, gender, and hiatal hernia size. LINX and Nissen fundoplication were both effective treatments for GERD. Severe dysphagia requiring endoscopic dilation was more common in LINX (50% vs. 0%; p=0.01). There was a non-statistically significant trend towards decreased gastrointestinal symptoms of bloating, flatulence, and diarrhea for LINX. These authors concluded that LINX and fundoplication are both effective and safe treatments for GERD. “Consideration to the distinct post-operative symptom profiles should be paid when selecting a surgical therapy for reflux disease.”

Riegler et al. [41] analyzed a prospective, multicenter registry of patients to undergo LINX and laparoscopic fundoplication for GERD. There were 202 LINX and 47 fundoplication patients with 1-year follow-up data at the time of their analysis. The fundoplication group was older with a greater frequency of large hiatal hernia and Barrett’s esophagus. GERD-health related quality of life score improved following surgery for both procedures. Moderate or severe regurgitation improved from 58.2 to 3.1% after LINX and 60.0 to 13.0% after fundoplication (p = 0.014).
Proton pump inhibitor medications were discontinued by 82% of LINX and 63.% of fundoplication patients (p = 0.009). Symptoms of excessive gas and abdominal bloating were reported by 10% of LINX and 32% of fundoplication patients (p ≤ 0.001). The authors of this study concluded that antireflux surgery should be individualized to the characteristics of each patient, taking into consideration anatomy and side effects. They felt that both LINX and fundoplication showed significant improvements in reflux control, with similar safety and reoperation rates. “In the treatment continuum of antireflux surgery, MSAD (Magnetic Sphincter Augmentation Device) should be considered as a first-line surgical option in appropriately selected patients without Barrett’s esophagus or a large hiatal hernia in order to avoid unnecessary dissection and preserve the patient’s native gastric anatomy.”

Reynolds was the lead author on 2 additional comparative studies evaluating LINX and fundoplication [42,43]. In the first comparative study to be published, from a series of 62 LINX and 117 laparoscopic Nissen fundoplications, 50 patients in both groups were matched using the “best-fit” model incorporating numerous preoperative variables. At 1 year after surgery, both groups had similar GERD Health Related Quality of Life scores and proton-pump inhibitor use. There were no patients with severe gas and bloating in the LINX group compared with 10.6% in the LNF group (p = 0.022). More fundoplication patients were unable to belch (8.5% of LINX and 25.5% of fundoplication; p = 0.028) or vomit (4.3% of LINX and 21.3% of fundoplication; p = 0.004). The incidence of postoperative dysphagia was similar between the groups. The authors concluded that analogous GERD patients had similar control of reflux symptoms with a lower incidence of gas bloat in LINX. In the second comparative trial by Reynolds et al, essentially the same cohort of patients was used to compare charges, complications, and outcome of LINX versus laparoscopic Nissen fundoplication at 1-year. There were 52 LINX and 67 fundoplication patients included. There was no significant difference between the mean charges. The fundoplication procedure was associated with a longer operative time and length of stay. Symptomatic outcomes and the ability to discontinue proton pump inhibitor medications were similar between procedures. As reported in the previously referenced publication, gas bloat as well as the ability to belch or vomit if needed was better following LINX. The authors concluded that fundoplication and LINX are comparable in symptom control, safety, and overall hospital charges.

Warren et. al. [44] published a multi-institutional retrospective cohort study of patients with GERD undergoing either LINX or laparoscopic Nissen fundoplication. Comparisons were made at 1 year for the overall group and for a propensity-matched group. There were 201 LINX and 214 fundoplication patients that were similar preoperatively with regards to age, gender, and GERD-HRQL scores. Obesity, dysphagia, higher DeMeester scores, Barrett’s esophagitis, and hiatal hernias were more prevalent in the fundoplication patients. Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of LINX. Mild dysphagia was higher for LINX (44 vs. 32 %, p=0.03). Resumption of daily PPIs was higher for LINX (24 vs. 12, p=0.02) with similar patient-reported satisfaction rates.



There was a trial at the Jacksonville, Mayo Clinic. This is what their description says,

Source: Jacksonville, FL Mayo Clinic






Asti et al published another comparative study evaluating outcomes following LINX and laparoscopic Toupet fundoplication [45]. Using the propensity score full matching method and generalized estimating equation, consecutive patients undergoing laparoscopic Toupet or LINX over the same time period were compared. Over a 7-year period, 103 patients underwent a laparoscopic Toupet and 135 a LINX procedure. All patients had a minimum 1-year follow-up. Over time, patients in both groups had similar GERD-HRQL scores, gas-related symptoms, dysphagia, and reoperation-free probability. In 2 concurrent cohorts of patients with early stage GERD undergoing laparoscopic Toupet or LINX and matched by propensity score analysis, health-related quality of life significantly improved and GERD-HRQL scores had a similar decreasing trend over time up to 7 years of follow-up. The authors conclude that laparoscopic Toupet and LINX provide similar disease-specific quality of life over time in patients with early stage GERD.

A search of the ClinicalTrials.gov website identified 8 clinical trials sponsored by Torax Medical. Five of these studies (all observational) have been completed. A post-approval study of the LINX reflux management system (NCT01940185) is active but not recruiting. The primary outcome measure of this study is a successful reduction of GERD-HRQL scores and adverse events to 60 months. The estimated study completion date is September 2019. The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease (NCT02505945) is open for enrollment with an estimated study completion date of April 2017. This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD). The percentage of subjects with resolution of the GERD symptom of interest in each arm will be compared for significance. The final study is not yet recruiting. https://clinicaltrials.gov/ct2/results?term=torax+medical&cond=%22Gastroesophageal+Reflux%22 (accessed March 24, 2016)

A review of the FDA MAUDE database (3/1/12-2/29/16) revealed 141 reported adverse events (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm). All 141 reports describe device explants. Over the entire post-FDA approval interval to date, there were 72 reports of devices removed for dysphagia primarily. There were 33 reports of devices removed for recurrent or persistent GERD. A total of 14 erosions are reported in the MAUDE database at the time of this search. It is not possible to determine the incidence of device removal or erosion from the MAUDE database as the denominator is not known, some events may be reported more than 1 time, and some are likely not reported at all.

There are 3 published case reports describing device removal at the time of this review. Dysphagia [46,47] and erosion [34] were the primary indications for device removal in these reports. Lipham [27] reported 1 erosion in 1,000 patients and Asti [35] reported 2 in 164 patients.

In November of 2015, the American Medical Association awarded the LINX device a new Category 1 CPT (Current Procedural Terminology) code that will be effective January 1, 2017.






The criteria for a category 1 CPT code are as follows (https://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/cpt-process-faq/code-becomes-cpt.page):

All devices and drugs necessary for performance of the procedure of service have received FDA clearance or approval when such is required for performance of the procedure or service

The procedure or service is performed by many physicians or other qualified health care professionals across the United States

The procedure or service is performed with frequency consistent with the intended clinical use (i.e. a service for a common condition should have high volume)

The procedure or service is consistent with current medical practice

The clinical efficacy of the procedure or service is documented in literature that meets the requirements set forth in the CPT code change application.






5. Limitations of currently published data

Patients used repeatedly in some publications

There may be a publication bias in favor of LINX, as several studies were either funded by the manufacturer or were performed by investigators affiliated with the manufacturer.

Most studies were performed in high volume centers in highly selected patients and may not reflect broader clinical practice, which may lead to underreporting of complications

Current studies lack randomization and blinding






6. Expert Panel Recommendation


This expert panel convened by the SAGES Technology and Value Assessment Committee finds that:



With regards to safety:

Safety analyses suggest the LINX procedure was associated with few serious adverse events and no reported mortality.
The most common anticipated side effect was acute dysphagia.
The reported rate of erosion is in the range of 0.1% to 0.2%. The published literature on erosions suggests that the device can be safely removed endoscopically or laparoscopically without serious adverse outcomes.
Some devices require removal, most often for recurrent GERD or persistent and/or severe dysphagia
No new patterns of failure or complications have been reported in long-term follow-up.
Longer-term follow-up supports the FDA conclusion that the device is safe.
With regards to efficacy, the panel concludes:

LINX implant results in pH normalization, improved quality of life, and complete cessation of regular PPI use on a consistent basis. The ability to belch and vomit is maintained following implantation of LINX, and de novo moderate-severe gas-bloat is uncommon.
When compared to laparoscopic fundoplication, rates of success in alleviating GERD symptoms and dysphagia are similar following LINX. Bloating side effects may be lower.
Longer-term follow-up data demonstrates that the LINX Reflux Management System is effective in the management of GERD.
Conclusions:

Longer-term (3-5 years) experience with the LINX Reflux Management System confirms the initial safety profile that led to FDA approval of the device.

The LINX device has been demonstrated to result in long-term GERD control based on symptomatic outcomes, PPI utilization, and pH studies.
LINX is a reasonable treatment option for appropriately selected patients with GERD who meet indications for antireflux surgery. The LINX procedure is part of the armamentarium in the treatment of GERD. As such, it should be performed by surgeons familiar with the workup and different management alternatives of GERD and not offered in isolation.

Implantation of the LINX device should be covered and reimbursed by insurance for appropriate patients who meet the selection criteria as described above.

Author Financial Disclosure/Conflict of Interest Statement

Dana Telem, MD: Research funding at Cook, Consulting Fees at Ethicon and Medtronic, Honoraria at Gore

Andrew Wright, MD: Honoraria at Medtronic.

Paresh Shah, MD: Consultant at Stryker, Zmicro, Olympus, Endoevolution

Matthew Hutter, MD: Reimbursed to attend Masters in MIS Forum by Olympus.

This document underwent prescreening review prior to submission to SAGES Board of Governors for approval by SD Schwaitzberg, MD and Patricia Sylla, MD







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Friday, November 30, 2018

The Different Tests to Diagnose Gastroparesis

There are may different tests to confirm the diagnosis of Gastroparesis. I wanted to write an article to list the different methods doctors can use to determine whether or not you have Gastroparesis. Sometimes, multiple tests are needed. Speak with your doctor before you are tested, just in case you are on any medications which can skew the test results (i.e. opiates like hydrocodone can slow down motility and prevent you from receiving an accurate diagnosis.

The first test I want to discuss is the breath test, which can be used to determine if someone has Gastroparesis or not. I have never been tested using the breath test method, so I researched the topic to understand it as well as to write about it.


Testing for Gastroparesis: The Breath Test


According to the US PHARMACIST,

"Gastric Emptying Breath Test

Kendra L. Sutton, PharmD Candidate
Florida A&M University
College of Pharmacy
Tallahassee, Florida

Cy D. Sims, PharmD Candidate
Florida A&M University
College of Pharmacy
Tallahassee, Florida

Marlon S. Honeywell, PharmD
Professor of Pharmacy Practice
Florida A&M University
College of Pharmacy
Tallahassee, Florida

Ellen Campbell, PhD
Associate Professor of Economic, Social and Administrative Pharmacy
Florida A&M University College of Pharmacy and Pharmaceutical Sciences
Tallahassee, Florida

Tracy A. Thomas, PT, PhD
Associate Professor of Physical Therapy
Florida A&M University
Tallahassee, Florida

Eboni Allen, MSN, ARNP-C
Bond Community Health Center
Tallahassee, Florida

Anneka J. Gaffney, MSN, ARNP-BC
Bond Community Health Center
Tallahassee, Florida

Temple Robinson, MD
Chief Medical Officer
Bond Community Health Center
Tallahassee, Florida

U.S. Pharm. 2015;40(12):HS36-HS40.



​Delayed gastric emptying, also known as gastroparesis, is a disorder that either slows or stops movement of food through the gastrointestinal (GI) tract. It commonly causes nausea, vomiting, heartburn, erratic blood glucose levels, and postprandial fullness.1 Normally, the smooth muscles of the GI tract move food down to the stomach and through the intestines, where it is excreted through the rectum. This process is controlled by the vagus nerve, a component of the parasympathetic nervous system. The most common causes of gastroparesis are diabetes mellitus and surgery; it may also be of unknown cause. Diabetes accounts for almost one-third of cases of gastroparesis, with about 5% to 12% of all diabetes patients experiencing this disorder.2,3 Diagnosis is most often determined by performing endoscopy or using scintigraphy—a specialized radiologic imaging technique—to measure the rate at which radioactive food passes through the GI tract. The Gastric Emptying Breath Test (GEBT) makes it possible to diagnose gastroparesis without the use of radioactive materials.




Gastric Emptying Breath Test

Developed by Advanced Breath Diagnostics, the GEBT is a non-radioactive test that utilizes carbon-13 (13C). Labeling with 13C stable isotope is essentially safe, as 1.1% of our bodies, and of the food we eat, consists of 13C; the remaining 98.9% consists of 12C.4 The GEBT test was developed for adult patients who are symptomatic for gastroparesis. The test measures the rate of gastric emptying of solids and aids in the diagnosis of gastroparesis. The test system utilizes a gas isotope ratio mass spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. Administration of the GEBT does not require a special facility, but it should be administered under the guidance of a healthcare professional.4 The GEBT is shown in FIGURE 1.




Source: in article




Test Administration

The GEBT is measured over a 4-hour time cycle. Detailed administration instructions can be found in Table 1. Multiple breath samples are obtained from the patient; sampling should be performed subsequent to an 8-hour fast. After providing multiple premeal breath samples (Table 2), the patient consumes the standard GEBT meal consisting of pasteurized scrambled egg mix containing a dose of 43 mg of 13C-Spirulina, 6 saltine crackers, and 6 ounces of potable water.5 The 13C-Spirulina is eventually passed through the GI tract to the intestines; it is in the intestines that the Spirulina is absorbed and metabolized to the 13CO2 expired in the breath. Single postmeal breath samples are subsequently collected (Table 2) at 45, 90, 120, 150, 180, and 240 minutes from the end of test-meal consumption. The post-meal breath samples are transmitted to a laboratory for assessment of 13CO2/12CO2 in each sample. By measuring the change in this ratio over time as compared to the pre-meal value, the rate of 13CO2 excretion can be calculated and the patient’s gastric-emptying rate determined.4,5 See FIGURE 2 for a diagram outlining the procedure.





Source: in article





Efficacy

Scintigraphy (The definition of Scintigraphy, according to the Dictionary,
"noun, MEDICINE. A technique in which a scintillation counter or similar detector is used with a radioactive tracer to obtain an image of a bodily organ or a record of its functioning."), a competitor to the GEBT, utilizes a radioisotope that is unsafe for patients who are having multiple tests performed, pregnant women, women who breast-feed, and children. Scintigraphy also requires special equipment and a specific testing site, whereas the GEBT can be implemented outside the clinical setting and breath samples are subsequently sent to a laboratory for analysis.4-6

In a clinical trial comparing the GEBT and scintigraphy, the GEBT was shown to be comparable to scintigraphy. Researchers compared the results from both the GEBT and scintigraphy and found that GEBT results agreed with scintigraphy results 73% to 97% of the time when measured from various time points during the test.4,5 The GEBT was also found to be safer than scintigraphy.



Adverse Effects/Contraindications

In the comparative study mentioned above, 13 participants complained of adverse effects.5,7 Adverse events experienced were often considered mild; these events included nausea, heartburn, diarrhea, dry heaves, abdominal pain, acid reflux, dizziness, and head cold. It was also determined later that many of these events were not related to the device. Contraindications to use of the GEBT include egg, milk, or wheat allergy, as the food product ingested contains these ingredients.5,8 Additionally, as the digestion of the product involves other organs such as the pancreas and liver, the GEBT is not recommended in patients with malabsorption, or who have diseases such as pancreatitis or hepatitis.



Conclusion

The GEBT is unique in that it provides a nonradioactive, noninvasive, orally administered product that performs as well as scintigraphy. The ease of use outside of the clinical setting also makes this device an attractive alternative to other available tests. For more information, contact Advanced Breath Diagnostics at (615) 376-5464.

REFERENCES
1. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Diseases. Gastroparesis. June 2012. www.niddk.nih.gov/health-information/health-topics/digestive-diseases/gastroparesis/Pages/facts.aspx. Accessed July 10, 2015.
2. Soykan I, Sivri B, Sarosiek I, et al. Demography, clinical characteristics, psychological and abuse profiles, treatment, and long-term follow-up of patients with gastroparesis. Dig Dis Sci. 1998;43:2398-2404.
3. Bytzer P, Talley NJ, Leemon M, et al. Prevalence of gastrointestinal symptoms associated with diabetes mellitus: a population-based survey of 15,000 adults. Arch Intern Med. 2001;161:1989-1996.
4. Szarka L, Camilleri M, Vella A, et al. A stable isotope breath test with a standard meal for abnormal gastric emptying of solids in the clinic and in research. Clin Gastroenterol Hepatol. 2008;6:635-643.
5. FDA. Gastric emptying breath test. www.accessdata.fda.gov/cdrh_docs/pdf11/P110015b.pdf. Accessed July 21, 2015.
6. Parkman HP, Hasler WL, Fisher RS. American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology. 2004;127:1589-1591.
7. Abell TL, Bernstein RK, Cutts T, et al. The American Motility Society Task Force on Gastroparesis. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006;4:263-283.
8. Park M, Camilleri M. Gastroparesis: clinical update. Am J Gastroenterol. 2006;101:1129-1139.
9. Gastric Emptying Breath Test [package insert]. Brentwod, TN: Advanced Breath Diagnostics, LLC; 2015.

To comment on this article, contact rdavidson@uspharmacist.com."



This was written in May of 2015 by DIATRIBE LEARN,

"The FDA recently announced the approval of the Gastric Emptying Breath Test (GEBT) as a diagnostic tool for gastroparesis – this condition is, though not as well known, a common complication of diabetes. Gastroparesis slows or stops the movement of food down the digestive tract from the stomach to the small intestine – this is caused by problems with stomach muscle contractions, which usually help move the food forward. In other words, digestion doesn't go nearly as well as it should. The GEBT works by measuring carbon dioxide in a patient’s breath over a four-hour period after eating a 'test meal.' The carbon dioxide measurement is used to calculate the rate at which food is emptied from the stomach.

GEBT should offer a major improvement over the current gold standard for gastroparesis diagnosis, gastric emptying scintigraphy. Gastric emptying scintigraphy requires eating radioactively labeled foods and measuring their digestion with an external scanner. As the GEBT does not require imaging equipment or training for the handling of radioactive materials, the hope is that it will be easier for more health care providers to use in their practices. A clinical study of 115 people conducted to support GEBT’s approval demonstrated that results from the GEBT agreed with the results of scintigraphy 73%-97% of the time.

Gastroparesis is a fairly common complication of diabetes, impacting an estimated 40% of type 1 and 30% of type 2 patients. In addition to causing symptoms like nausea and heartburn (see a full list of symptoms here), gastroparesis can make managing diabetes much more difficult, as it can lead to increased blood glucose variability and hypoglycemia. Gastroparesis remains an area of significant need, as no new therapies have been approved in the US in over 30 years and dietary interventions have not been clearly demonstrated to work. The approval of the GEBT is a positive step towards increased detection of this complication; for more information on diabetes and gastroparesis, please see the ADA’s page on it here. –AJW/ER"


Source: https://www.researchgate.net/figure/Methods-for-GE-assessment-by-breath-test-T-1-2-B-and-scintigraphy-T-1-2-S-and_fig1_251569573




Testing for Gastroparesis: The Smart Pill Test

I have already written about this before (in 2012), but was speaking about my own experiences with The Smart Pill Test. At the time I wrote this article, there was not a lot of information online about Gastroparesis, much less the different tests used to diagnose someone who has Gastroparesis.

Therefore, I wanted to put all of the testing I am aware of, to determine Gastroparesis, in the same article. The link to my article about The Smart Pill Test can be found here: http://www.emilysstomach.com/2012/08/smart-pill.html





Furthermore, GASTRO CURE says this about The Smart Pill,

"GI MONITORING SYSTEM
SmartPill is an ingestible, wireless capsule that measures pressure, pH and temperature as it transits the GI tract. This information is used to provide regional transit times including gastric emptying time, small bowel transit time, colonic transit time, combined small/large bowel transit time, whole gut transit time, pressure contraction patterns from the antrum and duodenum and motility indices.

Administered in the physician’s office, the SmartPill test is completely ambulatory and allows the patient to go about their normal routine during the course of the test. As the SmartPill Capsule passes through the GI tract, it transmits data to a SmartPill Data Receiver worn by the patient. Once the single-use capsule has passed from the body, the patient returns the data receiver to the Physician who then can download the collected data to a PC. The Physician then uses SmartPill’s MotiliGI software to display and analyze the data, providing the physician with test results in both graphical and report formats.



The SmartPill Wireless Motility Capsule

The SmartPill Capsule transits the intestines by peristalsis, or the normal rhythmic contraction of the intestinal muscles, and is capable of transmitting data continuously for at least five days. The single-use capsule is excreted naturally from the body, usually within a day or two.



SmartPill Data Receiver & Docking Station

The battery-operated SmartPill Data Receiver collects and stores the test data. The Receiver is capable of transmitting data for real-time monitoring of a test. It also stores a complete record of the data captured by the SmartPill Capsule for download to a PC after the test is complete.

The SmartPill Data Receiver must be worn by the patient for the duration of the test on a belt clip or a lanyard around their neck. The data receiver may be removed for sleeping or bathing but should be kept in close proximity at all times.

After completion of the test, the SmartPill Data Receiver is connected to the system computer using the SmartPill Docking Station. The docking station features an industry standard USB type 2.0 interface that is used to transfer captured data to the PC for analysis and data reconstruction using SmartPill’s MotiliGI software. The data analysis can be performed at the convenience of the physician in a single session or during multiple sessions without the need for the patient to be present.



SmartPill MotiliGI Software

SmartPill MotiliGI software comes pre-installed on the system PC and provides an graphical user interface. MotiliGI receives and processes data from the SmartPill Data Receiver, stores the data in a file on the system PC, provides a test summary and report, graphs for display purposes, and shows the data values captured during the SmartPill test. MotiliGI provides powerful data analysis tools, and affords the user a variety of test reporting and exporting options.



System Computer

The SmartPill GI Monitoring System is supplied with a personal computer which hosts MotiliGI software and supports communication between MotiliGI and the data receiver and docking station.



SmartPill Activation Fixture

The activation fixture contains very powerful magnets and is used to activate and deactivate the SmartPill Capsule."





Source: http://gastrocure.com/smart-pill/



I wanted to update this a bit since there is A LOT more information about The Smart Pill Test than when I was first diagnosed. For instance, I did not know that The Smart Pill Test could not work with certain conditions, like Crohn's Disease. So, I have actually learned a lot of new things about The Smart Pill test that I was unaware of before.


According to HEALTH ESSENTIALS,


"Gastroparesis: ‘Smart’ Pill Uncovers This Mysterious Stomach Condition: Data-Gathering Pill Moves Through Your GI Tract

If you have unexplained stomach problems, such as nausea, bloating, constipation, chronic abdominal pain or vomiting, you might swallow a pill — but not the medicated kind.

Instead, consider a 'smart' pill, which gathers data as it moves through your GI tract. This painless tool helps your doctor pinpoint the cause of your problem so you can get the best treatment, says gastroenterologist Michael Cline, DO.




How can the pill help?

Data gathered by such a pill could help your doctor diagnose a condition called gastroparesis, which causes food to move abnormally slowly from your stomach to the small intestine, while ruling out another GI condition, such as chronic constipation.

Gastroparesis, which means partial paralysis of the stomach, is a common condition for those with diabetes. The condition reduces your stomach’s ability to empty its contents, but it does not involve a blockage.

'Basically, gastroparesis is a stomach that doesn’t empty well,' says Dr. Cline.

And it’s a difficult disease to treat, he says. Treatment typically begins with adjustments to diet and medication. If those approaches don’t work, surgical treatments are the next steps.




How does the pill work?

The SmartPill® provides a simple, painless way to collect data about your GI tract without using radiation, Dr. Cline says. It’s an FDA-approved, disposable capsule that you swallow.

'It’s called ‘smart’ because it measures the acid level, the pressure level, the temperature and time of your GI tract,' he explains. 'It’s similar to the pill cam, which takes pictures inside your body. This is its sister, essentially.'

Instead of taking photos of the inside of your body, the SmartPill measures motility and movement of your gut. It wirelessly transmits data about your GI tract to a recorder that you wear on a belt clip or lanyard around your neck as you go about your daily activities.

'The recorder captures the data and we download it into a computer and print out what’s happening, from start to finish,' Dr. Cline says. 'We can get all of this data and measurements of motility and movement without any wires attached and without X-rays.'

Depending on how slowly your intestines move, the SmartPill typically works its way through your system in three to five days. If you have normal motility, it is in your stomach for less than four hours, in your small intestine for less than six hours and in your large intestine or colon for less than 59 hours.





Source: HERE





Ruling out other GI issues

The SmartPill can also help a physician rule out other gastric issues that can cause problems in your small intestine or colon.

'You want to make sure that you’re dealing with just gastroparesis and not another issue,' says Dr. Cline.

The one real benefit of the SmartPill over everything else available is that it measures all three sections of your intestine with one test. Dr. Cline says that not only are you looking for gastroparesis, but you’re also looking at your small intestine movement and colon movement.

'There’s no other test out there that can measure all three with one test,' he says. 'I tell patients you get a lot more bang for your buck with the SmartPill.'




Is a ‘smart’ pill right for you?

The SmartPill does not work for people with certain conditions, Dr. Cline says. These conditions include:

A history of strictures in your intestines, such as scarring (which can narrow the bowel passage)
Inflammatory bowel disease, like Crohn’s disease
A heart pacemaker (or pacemakers in other organs)

'The main risk of the SmartPill is it could get stuck,' he explains. 'If you have normal intestines, the SmartPill will not stick. If the pill gets stuck, you have a problem, obviously. You don’t want to give a patient who is at a high risk of having narrowing bowels the SmartPill.'

The FDA advises against giving the SmartPill to patients who have pacemakers.

Dr. Cline says he also advises patients who need an MRI to delay taking the SmartPill.

'The final contraindication, which is pretty rare, is if the patient has an MRI scheduled,” he says. 'You obviously don’t want to do it until after the MRI is over. You can’t go through an MRI with that pill inside of you.'"

For more information about The Smart Pill, please visit:

https://www.medtronic.com/covidien/en-us/products/motility-testing/smartpill-motility-testing-system.html

http://www.pain.ucdavis.edu/internalmedicine/gastro/smartpill.html

https://www.g-pact.org/gastroparesis/testing/smartpill




Testing for Gastroparesis: The Gastric Emptying Study

In February of 2013, I wrote an article about the Gastric Emptying Study and my experience doing the test. You can read about my experience in my article, along with pictures I took, documenting the testing, here: http://www.emilysstomach.com/2013/02/day-two-of-mayo-clinic-gastric-emptying.html


UW MEDICINE explains the Gastric Emptying Study,

"What is a gastric emptying scan?

​​ A gastric emptying scan (GES) is a nuclear medicine exam that uses a radioactive material that you will eat in a meal. You will eat this meal in the Radiology department before your scan. The radioactive material allows doctors to see how your stomach empties.

This scan is used to help diagnose conditions called motility disorders.​ These are conditions that change the way the stomach contracts and moves food into your intestines. A GES is a form of radiology, because radiation is used to take pictures of your body.



How does the scan work?

A gamma camera takes pictures as the radioactive food moves through your stomach. The camera detects the gamma rays emitted from the food. A computer then produces pictures and measurements of your stomach.



How should I prepare for the scan?

You will need to fast for 6 hours before the scan.

If you smoke, do not smoke the morning of the test and during the hours of the scan.

If you are a woman and you are still menstruating, it is best to have your scan done in the first 10 days of your menstrual cycle.



Do not take these drugs for at least 2 days before your test, unless your doctor tells you otherwise:

​​Drugs called prokinetic agents that speed up the motility of your GI tract. Some of these are metoclopramide (Reglan), erythromycin, tegaserod (Zelnorm), and domperidone (Motilium).

Drugs called anticholinergic antispasmodic agents that slow down the motility of your GI tract. Some of these are Bentyl, Donnatal, Levsin, Robinul, and Hyosyne.

Pain medicines called opiate analgesics. Some of these are codeine, demerol, Percocet (Oxycodone), Tylenol #3, Tylox, Oxycontin, Percodan, Fentanyl patch, morphine, Methadone, Vicodin (Hydrocodone), and Ultram (Tramadol).

Marijuana.

Do not take any laxatives the day before or any time during the test.

Note: It is OK to take relaxants(called benzodiazepines)such as Ativan, Valium, Librium, Xanax, and others. It is also OK to take anti-nausea medicines (called phenothiazines) such as Thorazine, Compazine, Phenergan, and others. These drugs do not affect gastric emptying.


You may take all other medicines the day of your test with small sips of water. Take these at least 2 hours before your test begins.


If you have severe nausea on the day of your test, we may give you medicine to reduce your nausea.



If You Have Diabetes

On the day of the test:

Your fasting blood glucose should be less than 275 mg/dL. A technologist will check your blood glucose before your test starts.

Please bring your insulin or other diabetes medicine with you. You may need to take it with your gastric emptying meal.



How is the scan done?

You will be given 2 small sandwiches, one filled with jam and one filled with 4 cooked egg whites that have been injected with a small dose of radioactive material. You will be asked to eat the sandwiches and drink water within 10 minutes. The egg will taste just like a regular egg. If you are allergic to eggs or wheat, please tell the person you schedule your appointment with. A different meal will be used.

After eating, you will be asked to lie flat on your back while the gamma camera take a picture of your stomach. You must lie still when the camera is taking pictures. If you move, the pictures will be blurry and may have to be taken again.



What will I feel during the scan?

Lying still on the exam table may be hard for some patients. The technologist will help make you comfortable.



How long will the scan take?

From start to finish, your gastric emptying scan will take about 4 hours.



There are 4 parts to the test:

First half hour: Eat meal, then take pictures with gamma camera (pictures take 5 minutes)
1 hour after meal: Take pictures (5 minutes)
2 hours after meal: Take pictures (5 minutes)
4 hours after meal: Take pictures (5 minutes)



After eating the meal:

​You may leave the Nuclear Medicine department between the times you have the pictures taken.

Do not eat or exercise until after the last set of pictures has been taken.



Who interprets the results and how do I get them?

When the test is over, the nuclear medicine doctor will review your images, write up a report, and talk with your doctor about the results. Your doctor will talk with you about the results and your treatment options."



Source: My own photo





According to HEALTH LINE (which has great information about the test and alternatives) also has information about Gastric Emptying Scans for children,

"Gastroparesis symptoms in children are similar to those seen in adults. Ask your doctor to administer this test to your child if they’re experiencing any of symptoms mentioned earlier.

The test for older children is identical to the test given to adults. If your child is a baby or infant, your doctor gives your child the radioactive food in milk or formula in an exam known as a milk study or liquid study. In this case, you may be instructed to bring your own formula or milk from home to make sure your child doesn't have an allergic reaction.

The radioactive substance is just as safe for your child as it is for an adult. The test usually takes about three hours for children. If your child is given the liquid study instead, the camera takes continuous images for about an hour. It’s important that your child remains still throughout the test. Make sure that you find a way to keep them occupied or calm before and during the test so that the results can be delivered smoothly.


The following items may help keep your child relaxed:

music
toys
movies
books
comfort objects, such blankets or pillows"




Source of a Gastric Emptying Scan: HERE





Testing for Gastroparesis: The Heidelberg pH Diagnostic Test

This test is very similar to The Smart Pill Test. I wrote about this test in August. You can read my blog article about it here: http://www.emilysstomach.com/2018/04/heidelberg-ph-test.html. I also included an excerpt below:


"What is a Heidelberg pH Test?

The Test will accurately verify the presence of a common Digestive Disorder

The Physician will require a complete Medical History before the Test

There will be a Transceiver that is placed over the Patient’s stomach during the test.

The pre test instructions will help achieve the most accurate results.

There is no discomfort during a Heidelberg pH test. Patients are relaxed and comfortable.

Remember to grab a good old fashioned distraction to pass the time.

Due to wireless interference, cell phones and personal electronic devices may need to be powered off.

The results are immediate so the Physician may have the post test consultation the same day.




Heidelberg pH Diagnostic Test will accurately verify the presence of low stomach acid production, high stomach acid production, no acid in the stomach, Dumping Syndrome, Acute or sub Acute Gastritis, Heavy Mucus in the stomach, and Pyloric insufficiency.

The Test is accomplished by measuring the time it takes for the acid producing cells (Parietal Cells) in the stomach to produce the required Hydrochloric acid. The strength of the acid (pH) is also measured during the test.

Patients are required to complete a consent form for the Physician’s Office Staff. If you have reservations about having a pH test, please discuss them with the Physician. Mental anguish and stress will only alter the test results.

The Technician will calibrate the pH Capsule to ensure it accurately records the pH values. The Technician will then place a transceiver over the Patient’s stomach. The transceiver receives and transmits the information from the pH Capsule and sends it wirelessly to the computer where the information is displayed. The nurse will rinse the pH Capsule and give it the Patient to swallow with a sip of water.

There is no discomfort during a Heidelberg pH Test. Patients are asked to relax and get comfortable while the test is being done. Remember to grab a good old fashioned distraction to pass the time.

Results are ready for the Physician to review as soon as the Technician ends the Test. Many Physicians opt to have a post test consultation as soon as the test is complete. In many cases the doctor will establish a treatment protocol on the same day. In many instances, after testing and treatment, patients stated that they feel better and healthier in just two or three days.


Unlike other procedures, the Heidelberg pH diagnostic test is an in-office procedure that does not require sedation or the use of a stomach tube.

There is no trauma or discomfort associated with our test, and the results of the Heidelberg test are available to the doctor as soon as the test is complete."


Source:HERE




Testing for Gastroparesis: The pH Bravo Test

I have had this test done as well. After I was first diagnosed with Gastroparesis, my doctor sent me to the Mayo Clinic to meet with a motility specialist there. I had to go off all of my other medications for a month before the doctor at Mayo would even see me, as I have mentioned before.

My personal experience was in February of 2013, and you can read the article here:

http://www.emilysstomach.com/2013/02/mayo-clinic-day-four-bravo-test.html








But, I want to discuss the test because the test now is a bit different than when I took it in 2013. Even though it is used as testing for GERD, my personal test found fifty-five events in twenty-four hours, with forty-six of them being vomiting. So, it might measure for GERD but my test was used to prove my vomiting with Gastroparesis, and how much I vomit.




Source: HERE





According to the CLEVELAND CLINIC,

"How does the Bravo esophageal pH test work?

A small capsule, about the size of a gel cap, is temporarily attached to the wall of the esophagus during an upper endoscopy. The capsule measures pH levels in the esophagus and transmits readings by radio telecommunications to a receiver (about the size of a pager) worn on your belt or waistband. The receiver has several buttons on it that you will press to record symptoms of GERD such as heartburn (the nurse will tell you what symptoms to record). You will be asked to maintain a diary to record certain events such as when you start and stop eating and drinking, when you lie down, and when you get back up. This will be explained by the nurse.



How do I prepare for the Bravo esophageal pH test?

Let your physician know if you have a pacemaker or implantable heart defibrillator, a history of bleeding problems, dilated blood vessels, and any other previously known problems with your esophagus.


Seven days before the monitoring period, do not take proton pump inhibitors such as omeprazole (Prilosec®), lansoprazole (Prevacid®), rabeprazole (Aciphex®), pantoprazole (Protonix®), esomeprazole (Nexium®).

Two days (48 hours) before the monitoring period, do not take the H2 blockers ranitidine (Zantac®), cimetidine (Tagamet®), famotidine (Pepcid®), nizatidine (Axid®); or the promotility drug, metoclopramide (Reglan®).

Six hours before the monitoring period, do not take antacids (such as Alka-Seltzer®, Gaviscon®, Maalox®, Milk of Magnesia®, Mylanta®, Phillips®, Riopan®, Tums® or any other brands).

Four to 6 hours before your appointment do not eat or drink.

Please note: Occasionally, your doctor may want you to continue taking a certain medication during the monitoring period to determine if it is effective.




Once the test has begun, what do I need to know and do?

Activity: Follow your usual daily routine. Do not reduce or change your activities during the monitoring period. Doing so can make the monitoring results less useful. Note: Do not get the receiver wet; it is not waterproof!

Eating: Eat your regular meals at the usual times. If you do not eat during the monitoring period, your stomach will not produce acid as usual, and the test results will not be accurate. Eat at least 2 meals a day. Eat foods that tend to increase your symptoms (without making yourself miserable). Avoid snacking. Do not suck on hard candy or lozenges and do not chew gum during the monitoring period.
Lying down: Remain upright throughout the day. Do not lie down until you go to bed (unless napping or lying down during the day is part of your daily routine).

Medications: Continue to follow your doctor’s advice regarding medications to avoid during the monitoring period.

Recording symptoms: Press the appropriate button on the receiver when symptoms occur (as discussed with the nurse). Record the time you start and stop eating and drinking (anything other than plain water). Record the time you lie down (even if just resting) and when you get back up. The nurse will explain this.

Unusual symptoms or side effects: If you think you may be experiencing any unusual symptoms or side effects, call your doctor.
You will return the receiver and diary when the monitoring period is over. The information on the receiver and diary will be downloaded to a computer and the results will be analyzed. Preliminary study data will be reviewed with you if you desire.




After completion of the study:

Resume your normal diet and medications.

Your doctor will discuss the results of your test with you during your next scheduled appointment.

Normal activities – such as swallowing, eating and drinking – will cause the disposable pH capsule to detach and pass through the digestive tract in 7 to 10 days on average.

No MRI exams (magnetic resonance imaging) should be performed for 30 days following capsule insertion."


These are the five main tests that are preformed to properly diagnose Gastroparesis. Doctors may use a combination of these tests to determine if:

1. You have Gastroparesis
2. How mild to severe your Gastroparesis is

I did not really get into endoscopies and upper GI testing, like barium swallows, because those are not the best tests to determine whether or not someone has Gastroparesis. These tests can definitely be useful, and I am not debating that, but there are a lot of things that can missed on tests like these. My GI did an endoscopy on me, before he hospitalized me to do more testing (before I even knew what Gastroparesis was) and when I came to, he started getting on to me about eating after midnight and not telling them. I swore to him that I had not eaten or had anything to drink after midnight. I told him the last thing I ate, which was three days before the endoscopy, was a salad. He was appalled because I still had undigested salad greens sitting in my stomach. After that, he hospitalized me and did a gastric emptying study. At the end of the day, endoscopies and barium swallows can help confirm a diagnosis, but the other tests are a lot more accurate in diagnosing Gastroparesis, in my opinion, but you should talk with your doctor about the different test options if you suspect that you have Gastroparesis, or if a family member does.