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Thursday, June 7, 2018

A Collection of Gastroparesis Studies and Research

This article is from 2016, but I still think it's worth sharing. I also want to say that I will keep updating this article for any new studies, research, and new treatments for Gastroparesis. I want it to stay current and it might help someone.




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According to EMORY:

"Minimally Invasive Procedure for Gastroparesis Shows Promising Results


A minimally invasive procedure at Emory University Hospital is showing promise in patients with gastroparesis, a digestive disorder in which the stomach does not empty food in a normal manner. The results of two small Emory studies were presented recently at the American College of Gastroenterology (ACG) in Las Vegas, where the researchers accepted the 2016 ACG Governor’s Award for Excellence in Clinical Research and the ACG Presidential Poster Award.

Gastroparesis occurs in diabetic patients and other patients with no underlying causes, where the muscles of the stomach and intestines do not properly function. Food then moves slowly or stops moving through the digestive tract.

In one study, Emory researchers performed a retrospective review of data in 10 patients who underwent gastric peroral endoscopic pyloromyotomy or G-POEM for gastroparesis. G-POEM involves guiding a small knife through an endoscope into the submucosal tunnel. Once there, an incision is made in the pyloric ring muscle to release the tightness of that muscle and normalize gastric emptying.

"In these 10 patients, clinical success was defined by improvement of symptoms measured with a decrease in the Gastroparesis Cardinal Score Index (GCSI) and no recurrent hospitalization," says Sunil Dacha, MD, assistant professor of medicine in the Division of Digestive Diseases, Emory University School of Medicine, and a former advanced endoscopic fellow with Qiang Cai, MD, professor of medicine in the Division of Digestive Diseases at Emory, who is an expert in the minimally invasive procedure. "We found G-POEM was clinically successful in eight of the 10 patients (80 percent) with a decrease in mean GCSI from 30.1 prior to the procedure to 12.8 at follow-up."

Gastric emptying studies were obtained on seven of the 10 patients following G-POEM. Results showed gastric emptying had normalized in five patients and improvements were noted in two other patients. Mean four-hour gastric retention decreased from 62.5 percent to 25.4 percent after G-POEM, indicating the stomach emptied much faster at four hours after a meal. A follow-up questionnaire also highlighted significant improvement in quality of life in several areas.

One patient in the study had no response and required hospitalization 15 days after G-POEM and another patient showed no improvement in symptoms.

A second study, presented at the ACG by Abhinav Koul, MD, a former Emory medical resident who worked with Cai, detailed three patients with gastroparesis who had failed gastric electrical stimulation, but showed improvement following G-POEM. Electrical stimulation of the gastric nerves by a small implantable device is one treatment option for patients with gastroparesis. In this retrospective study, Emory researchers determined G-POEM can be performed safely as a salvage therapy for patients with gastroparesis who failed treatment with a gastric stimulator.

The study also found G-POEM improved symptoms (mean GCSI decreased by an average of 64 percent from 27 to 10) as well as gastric emptying (60.6 percent to 18.3 percent mean average) in these patients. However, more data is needed to further define the role of G-POEM in this challenging patient population. Koul is now a clinical assistant professor at the Medical College of Georgia-UGA Medical Partnership at Athens Regional Medical Center.

"G-POEM is showing some positive results as an additional therapeutic modality for patients with gastroparesis who suffer with delayed gastric emptying," says Cai, who also serves as the director of the Advanced Endoscopy Fellowship at Emory. "We are only one of a few centers in the U.S. offering this specialized procedure."

In 2012, Cai started the POEM procedure at Emory University Hospital for patients with achalasia, a disorder of the esophagus that causes swallowing difficulties. He then developed the G-POEM program at the hospital, in hopes of finding alternative treatments for patients with gastroparesis."


Source: The above article



According to THE CLEVELAND CLINIC:


"New Program Offers Multidisciplinary Treatment and Hope to Patients with Gastroparesis


For patients with gastroparesis, long-term relief from nausea, vomiting and bloating may have seemed like an impossible dream. However, medical experts have discovered the secret to conquering this chronic condition. Effective patient care for gastroparesis requires innovative treatment combined with the expertise of physicians from multiple disciplines.


Challenges of traditional treatment

The most common treatments for gastroparesis include pain management, medication and surgery. However, using just one of these treatments is unlikely to relieve the patient’s symptoms. Physicians must consider the patient’s overall health, including diet, psychology and pain levels. When patients receive treatments from physicians in multiple disciplines, the overall treatment plan usually lacks cohesion and focus.

Because gastroparesis is such a rare disorder, few medical centers have had enough exposure to patients with this condition to develop effective treatment plans. Plus, the therapies are evolving so rapidly that many hospitals are struggling to keep up with the changes.

As a result, gastroparesis patients may spend a lot of time and money on various physicians and specialists who are not addressing their condition from a holistic viewpoint. A history of poor, ineffective treatments has left many gastroparesis patients very frustrated.


Convenient, multidisciplinary care

At the Digestive Disease & Surgical Institute, gastroparesis is the number one reason for patient referrals. This influx of patients gives physicians abundant opportunities to gain practical experience diagnosing and treating gastroparesis.

Currently led by Surgical Endoscopist John Rodriguez, MD, and Gastroenterologist Michael Cline, DO, the Gastroparesis Clinic offers a centralized place for patients to consult multiple specialists, including psychologists, gastroenterologists, pain specialists, nutritionists and surgical endoscopists. 'Because they have experience working together to support patients with gastroparesis, they know what works and what doesn’t,' explains Director of Surgical Endoscopy Matthew D. Kroh, MD. 'They also know whom to consult when they’ve hit a roadblock in the process.'

Following the patient’s initial appointments, the multidisciplinary team develops a treatment plan that’s tailored to every aspect of the patient’s condition. Throughout treatment, care team members stay in touch with each other and the patient, making adjustments as needed.The convenience of the Gastroparesis Clinic also contributes to patient ease. 'Our patients can schedule their appointments with multiple doctors over the course of one or two days, making scheduling one less thing that they have to worry about,' says Dr. Kroh. This is especially helpful for patients who must travel a considerable distance to seek treatment at Cleveland Clinic.



POP: Using surgical tools in endoscopic applications

The Digestive Disease & Surgical Institute’s Developmental Endoscopy Group recently used POP to treat several patients with gastroparesis. Led by Dr. Kroh and Medical Director Mansour Parsi, MD, MPH, these experts in gastroenterology, general surgery, colorectal surgery and interventional endoscopy work together to implement and refine POP procedures.

During POP, the physician cuts the pylorus, a muscular valve that empties the stomach, without surgery. Using advanced endoscopic tools, the entire procedure is performed through the mouth without the need for incisions. After the lining of the stomach is opened, only the pylorus is divided under high-definition vision, improving the emptying ability of the stomach.

By using an endoscopic method, the physician decreases the morbidity associated with laparoscopic surgery while delivering the same effectiveness for the patient. Traditional laparoscopic methods for dividing the pylorus muscle can result in pain from the incisions, herniation or leakage from the closure. POP eliminates the access trauma induced by open and laparoscopic surgery.

Many of the new endoscopic instruments and knives used in POP originated in Japan where physicians used them to remove early cancers. These pioneers in minimally invasive technology created a platform that allows Cleveland Clinic physicians to use surgical tools in innovative endoscopic applications.



Promising patient outcomes

The initial patient outcomes for POP procedures performed by the Digestive Disease & Surgical Institute look very promising. Immediately following treatment, physicians have noted symptomatic improvement as well as gastric emptying improvement.

'To finally be able to manage the full spectrum of care for patients who have suffered with gastroparesis for so many years is very rewarding,' says Dr. Kroh. 'Giving these patients the support and treatment they really need — and watching them steadily improve — makes it all worthwhile.'



Ongoing training and development

According to Dr. Kroh, the Developmental Endoscopy Group is busy training physicians in digestive disease fellowship programs at Cleveland Clinic to adopt the latest laparoscopic and endoscopic techniques. “When they graduate, these physicians will be fully prepared to help other hospitals implement innovative treatment programs for gastroparesis,” he reveals.

The Gastroparesis Clinic is a valuable resource for digestive disease physicians who lack experience in treating gastroparesis. 'We would love to have administrators or physicians from other hospitals work with us and do case observations through our clinic,' explains Dr. Kroh. 'This training would help them benefit from our expertise and put our technologies and treatments into practice.'

In support of the Gastroparesis Clinic, the Developmental Endoscopy Group will continue to develop laparoscopic and endoscopic procedures to treat patients with gastroparesis and other digestive disorders.



Source: Article above




According to HEALIO (from 2016):

"Latest Gastroparesis News, Research for Health Care Providers


An estimated 5 million Americans have gastroparesis, according to the International Foundation for Functional Gastrointestinal Disorders.

Michael Camilleri, MD, and colleagues detailed the management of gastroparesis in guidelines issued by the American College of Gastroenterology.

'Gastroparesis is identified in clinical practice through the recognition of the clinical symptoms and documentation of delayed gastric emptying,' they wrote. 'Symptoms from gastroparesis include nausea, vomiting, early satiety, postprandial fullness, bloating, and upper abdominal pain. Management of gastroparesis should include assessment and correction of nutritional state, relief of symptoms, improvement of gastric emptying and, in diabetics, glycemic control.'

In a statement for the record, Sen. Tammy Baldwin, D-Wis., brought attention to the condition, which can lead to issues in managing blood glucose levels, dehydration and malnutrition.

'While there is no cure for gastroparesis, some treatments, such as dietary measures, medications, procedures to maintain nutrition, and surgery, can help reduce symptoms,' she said. 'Unfortunately, gastroparesis is a poorly understood condition and so patients often suffer from delayed diagnosis, treatment and management of this disorder. As such, further research and education are needed to improve quality of life for this patient population.'

Relamorelin improves diabetic gastroparesis symptoms

Adults with diabetic gastroparesis experienced accelerated gastric emptying and reduced vomiting with 10 µg of subcutaneous relamorelin administered twice daily, according to phase 2 trial data. Read more.

G-POEM promising minimally invasive treatment for refractory gastroparesis

Mouen A. Khashab, MD, associate professor of medicine and director of therapeutic endoscopy at Johns Hopkins Hospital in Baltimore, discusses positive results from a study of gastric peroral endoscopic myotomy.

FDA issues draft guidance on clinical evaluation of gastroparesis drugs

'The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic and idiopathic gastroparesis,' the FDA wrote in the draft guidance. 'Specifically, this guidance addresses the [FDA’s] current thinking regarding clinical trial designs and clinical endpoint assessments to support development of gastroparesis drugs,' for which there is an “urgent medical need.'

Age, sex, obesity among factors that affect outcomes in gastroparesis

A recent study found that less than a third of patients with gastroparesis had significant symptom relief after treatment, and identified a number of independent predictors of symptom reduction. Read more.

FDA approves breath test for diagnosis of gastroparesis

The FDA today approved the Gastric Emptying Breath Test, or GEBT, a novel noninvasive diagnostic for gastroparesis.


References:

Camilleri M, et al. Am J Gastroenterol. 2013;doi: 10.1038/ajg.2012.373.

Statement in the Record Recognizing Gastroparesis Awareness Month. International Foundation for Functional Gastrointestinal Disorders website. Accessed August 18, 2016. (**Note, you can read more about topics and procedures in the article itself**)



Source: My friend Alley made this image.






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