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Saturday, June 10, 2017

The Vagus Nerve Stimulator

The Vagus Nerve Stimulator (VNS) is a medical treatment that involves delivering electrical impulses to the vagus nerve. The Vagus Nerve Stimulator, which is new to me so I wanted to do research on it, definitely would help a variety of conditions like epilepsy, depression, multiple sclerosis, headache, pain and Alzheimer's disease. It would probably even help with gastroparesis as well, though I'd check with your doctor first to be one hundred percent sure. Gastroparesis and DTP are caused by vagus nerve damage. If it sends electric impulses down your vagus nerve, it might help your stomach muscles contract and help with gastric emptying. There isn't enough research about Gastroparesis and the VNS so I cannot give you a definitive answer on whether it would help with Gastroparesis or not. However, I did research on the VNS itself, below, because I am not really familiar with it yet. I hope the research helps and I am going to mention this procedure to my GI to see if he would recommend it or if it can be used for Gastroparesis. It has been approved by the FDA for cluster headaches, which I found interesting reading the articles below.

If you are not familiar with the vagus nerve and how much it controls, please read my other article. The link is below:


The Mayo Clinic describes the Vagus Nerve Stimulator (VNS) as:

"Vagus nerve stimulation is a procedure that involves implantation of a device that stimulates the vagus nerve with electrical impulses.

There's one vagus nerve on each side of your body, running from your brainstem through your neck to your chest and abdomen.

Vagus nerve stimulation is most often used to treat epilepsy when other treatments haven't worked. Vagus nerve stimulation is also a treatment for hard-to-treat depression that hasn't responded to typical therapies.

Researchers are currently studying vagus nerve stimulation as a potential treatment for a variety of conditions, including multiple sclerosis, headache, pain and Alzheimer's disease.

In conventional vagus nerve stimulation, a device is surgically implanted under the skin on your chest, and a wire is threaded under your skin connecting the device to the left vagus nerve. The right vagus nerve is not used because it carries fibers that supply nerves to the heart.

When activated, the device sends electrical signals along the vagus nerve to your brainstem, which then sends signals to certain areas in your brain.

New, noninvasive vagus nerve stimulation devices, which do not require surgical implantation, have been approved for use in Europe to treat epilepsy, depression and pain but have not yet been approved for use in the U.S. An implantable device that stimulates the right vagus nerve is also under study for the treatment of heart failure.

Before the procedure

Before surgery, your doctor will do a physical examination. You may need blood tests or other tests to make sure you don't have any health concerns that might be a problem.

Your doctor will have you start taking antibiotics before surgery to prevent infection.

During the procedure

Surgery to implant the vagus nerve stimulation device is done either on an outpatient basis, allowing you to go home that same day, or on an inpatient basis, requiring an overnight stay in the hospital.

The surgery usually takes one to two hours. You may remain awake but have medication to numb the surgery area (local anesthesia) or you may be unconscious during the surgery (general anesthesia).

The surgery itself doesn't involve your brain. Two small incisions are made, one on your chest and the other on the left side of the neck.

The pulse generator is implanted in the upper left side of your chest. The device is meant to be a permanent implant, but it can be removed if necessary.

The pulse generator is about the size of a stopwatch and runs on battery power. A lead wire is connected to the pulse generator. The lead wire is guided under your skin from your chest up to your neck, where it's attached to the left vagus nerve through the second incision.

After the procedure

The pulse generator is turned on during a visit to your doctor's office a few weeks after surgery. Then it can be programmed to deliver electrical impulses to the vagus nerve at various durations, frequencies and currents.

Vagus nerve stimulation usually starts at a low level and is gradually increased, depending on your symptoms and side effects.

Stimulation is programmed to turn on and off in specific cycles. You may have some tingling sensations or slight pain in your neck when the nerve stimulation is on.

Usually, the stimulations are set to occur every one to three minutes. Programming is performed at the physician's office using a hand-held programming device.

The stimulator doesn't detect seizure activity or depression symptoms. When it's turned on, the stimulator turns on and off at the intervals selected by your doctor.

You'll be given a hand-held magnet so that you can initiate a stimulation yourself if you or others sense the beginning of a seizure.

The magnet can also be used to temporarily turn off the vagus nerve stimulation, which may be necessary when you do certain activities such as public speaking, singing or exercising, or when you're eating if you have swallowing problems.

You must visit your doctor periodically to make sure that the pulse generator is working correctly and that it hasn't shifted out of position. Most people see their doctor once or twice a year for this purpose.

You should also contact your doctor before you have any medical tests, such as magnetic resonance imaging (MRI), which might interfere with your device, or have another medical device implanted.


Vagus nerve stimulation isn't a cure for epilepsy. Most people with epilepsy won't stop having seizures or taking epilepsy medication altogether after the procedure.

But many will have fewer seizures, up to 20 to 50 percent fewer. Seizure intensity may lessen as well.

It can take as long as 18 months of vagus nerve stimulation before you notice any significant reduction in seizures. Vagus nerve stimulation may also shorten the recovery time after a seizure.

People who've had vagus nerve stimulation to treat epilepsy may also experience improvements in mood and quality of life.

Research is still mixed on the benefits of vagus nerve stimulation for the treatment of depression.

Some studies suggest the benefits of vagus nerve stimulation for depression accrue over time, and it may take several months of treatment before you notice any improvements in your depression symptoms.

In addition, vagus nerve stimulation doesn't work for everybody, and it generally isn't meant to replace traditional treatments.

Additionally, some health insurance carriers may not pay for this procedure.

Studies of vagus nerve stimulation as a treatment for conditions, such as Alzheimer's disease, migraine and multiple sclerosis, have been too small to draw any definitive conclusions about how well it may work for those problems. More research is needed."

In vagus nerve stimulation, an implanted pulse generator and lead wire stimulate the vagus nerve, which leads to stabilization of abnormal electrical activity in the brain.

According to Wikipedia, it has a lot of different medical uses such as,

"Because the vagus nerve is associated with many different functions and brain regions, research is being done to determine its usefulness in treating other illnesses, including various anxiety disorders, Alzheimer's disease, migraines, fibromyalgia, obesity, and tinnitus.

Alcohol addiction
Atrial fibrillation
Bulimia nervosa
Burn-induced organ dysfunction
Chronic heart failure
Chronic intractable hiccups
Comorbid personality disorders
Coronary artery disease
Dravet syndrome
Heroin seeking behavior
Intestinal epithelial barrier breakdown
Lennox–Gastaut syndrome
Mood disorders in elderly population
Multiple sclerosis
Obsessive compulsive disorder
Peripheral arterial occlusion disease
Postoperative cognitive dysfunction in elderly patients
Rasmussen's encephalitis
Severe mental diseases
Spinal trigeminal neuronal
Transient focal cerebral ischemia
Trauma-hemorrhagic shock
Traumatic brain injury
Vaginal-cervical self-stimulation in women with complete spinal cord injury
Vegetative states after traumatic brain injury
Visceral pain-related affective memory
Other brain stimulation techniques used to treat depression include electroconvulsive therapy (ECT) and cranial electrotherapy stimulation (CES). Deep brain stimulation is currently under study as a treatment for depression. Transcranial magnetic stimulation (TMS) is under study as a therapy for both depression and epilepsy. Trigeminal Nerve Stimulation (TNS) is being researched at UCLA as a treatment for epilepsy."

Unless you have a surgically implanted device you actually cannot directly stimulate your vagus nerve; however, you can indirectly stimulate your vagus nerve to relieve keyed up or shut down nervous system states. Remember, your vagus nerve passes through your belly, diaphragm, lungs, throat, inner ear, and facial muscles. Therefore, practices that change or control the actions of these areas of the body can influence the functioning of the vagus nerve through the mind-body feedback loop.

According to Dr. Arielle Schwartz, you can try these from the comfort of your living room:

"Humming: The vagus nerve passes through by the vocal cords and the inner ear and the vibrations of humming is a free and easy way to influence your nervous system states. Simply pick your favorite tune and you’re ready to go. Or if yoga fits your lifestyle you can “OM” your way to wellbeing. Notice and enjoy the sensations in your chest, throat, and head.

Conscious Breathing: The breath is one of the fastest ways to influence our nervous system states. The aim is to move the belly and diaphragm with the breath and to slow down your breathing. Vagus nerve stimulation occurs when the breath is slowed from our typical 10-14 breaths per minute to 5-7 breaths per minute. You can achieve this by counting the inhalation to 5, hold briefly, and exhale to a count of 10. You can further stimulate the vagus nerve by creating a slight constriction at the back of the throat and creating an “hhh”. Breathe like you are trying to fog a mirror to create the feeling in the throat but inhale and exhale out of the nose sound (in yoga this is called Ujjayi pranayam).

Valsalva Maneuver: This complicated name refers to a process of attempting to exhale against a closed airway. You can do this by keeping your mouth closed and pinching your nose while trying to breathe out. This increases the pressure inside of your chest cavity increasing vagal tone.

Diving Reflex: Considered a first rate vagus nerve stimulation technique, splashing cold water on your face from your lips to your scalp line stimulates the diving reflex. You can also achieve the nervous system cooling effects by placing ice cubes in a ziplock and holding the ice against your face and a brief hold of your breath. The diving reflex slows your heart rate, increases blood flow to your brain, reduces anger and relaxes your body. An additional technique that stimulates the diving reflex is to submerge your tongue in liquid. Drink and hold lukewarm water in your mouth sensing the water with your tongue.

Connection: Reach out for relationship. Healthy connections to others, whether this occurs in person, over the phone, or even via texts or social media in our modern world, can initiate regulation of our body and mind. Relationships can evoke the spirit of playfulness and creativity or can relax us into a trusting bond into another. Perhaps you engage in a lighthearted texting exchange with a friend. If you are in proximity with another you can try relationship expert, David Snarch’s simple, yet powerful exercise called 'hugging until relaxed.' The instructions are to simply 'stand on your own two feet, place your arms around your partner, focus on yourself, and to quiet yourself down, way down.'

Knowing practices for self-care are important. However, it is also important to know how and when to seek out professional therapeutic help. Asking for help can often be the hardest step. You do not need to walk the healing path alone."


The risks for the VNS, include side effects for the stimulator itself and surgical risks. According to the Mayo Clinic, they are,

"For most people, vagus nerve stimulation is safe. But it does have some risks, both from the surgery to implant the device and from the brain stimulation.

Surgery risks

Surgical complications with vagus nerve stimulation are rare and are similar to the dangers of having other types of surgery. They include:

Pain where the cut (incision) is made to implant the device
Incision scarring
Difficulty swallowing
Vocal cord paralysis, which is usually temporary, but can be permanent
Side effects after surgery

Some of the side effects and health problems associated with vagus nerve stimulation can include:

Voice changes
Throat pain
Chest pain
Breathing problems, especially during exercise
Difficulty swallowing
Abdominal pain or nausea
Tingling or prickling of the skin
Slowing of the heart rate (bradycardia)
For most people, side effects are tolerable. They may lessen over time, but some side effects may be bothersome for as long as you use vagus nerve stimulation.

Adjusting the electrical impulses can help minimize these effects. If side effects are intolerable, the device can be shut off temporarily or permanently."

EDIT September 28, 2017: A coma patient was comatose for fifteen years. Doctors placed a vagus stimulator in the coma patient and noticed that it increased the patient's brain activity. He woke up and can now communicate.

The article from The New York Post ( says,

"A car crash victim left in a coma for 15 years has shown signs of life after a [vagus] nerve stimulator was implanted into his chest by neurosurgeons.

Doctors in France were able to stimulate nerves and have been able to challenge the long-held belief that disorders of consciousness that persist for longer than 12 months are irreversible.

Dr. Angela Sirigu of Institut des Sciences Cognitives Marc Jeannerod in Lyon said: 'By stimulating the vagus nerve, we show that it is possible to improve a patient’s presence in the world.'

The vagus nerve connects the brain to many other parts of the body, including the gut, and it is known to be important in waking up, alertness, and many other essential functions.

VNS stimulation was shown to revive consciousness in comatose patients.

Image Credit:

To test the ability of vagus nerve stimulation (VNS) to restore consciousness, the researchers wanted to select a difficult case to ensure that any improvements couldn’t be explained by chance.

They looked at a patient who had been lying in a vegetative state for more than a decade with no sign of improvement.

The results, which were published in the journal Current Biology, show that after one month of VNS, the patient’s attention, movements and brain activity significantly improved.

PET scans show increased brain activity in comatose patients after VNS.

The patient began responding to simple orders that had been impossible before and was able to follow an object with his eyes and turn his head upon request.

The patient’s mother reported an improved ability to stay awake when listening to his therapist reading a book.

After stimulation, the researchers also observed responses to 'threat' that had been absent. For example, when an examiner’s head suddenly approached the patient’s face, he reacted with surprise by opening his eyes wide.

After many years in a vegetative state, he had entered a state of minimal consciousness.

Brain scans also showed major changes and improvements in movement, sensation, and awareness and also showed increased brain functional connectivity.

A positron emission tomography scan showed increases in metabolic activity in both cortical and subcortical regions of the brain.

The scientists say it shows that the right intervention can yield changes in consciousness even in the most severe clinical cases.

Sirigu said: 'Brain plasticity and brain repair are still possible even when hope seems to have vanished.'

The team now hopes the findings will also advance understanding of the capacity of our minds to produce conscious experience."

Tuesday, June 6, 2017

Nissen Fundoplication

A Nissen fundoplication, or laparoscopic Nissen fundoplication when performed via laparoscopic surgery, is a surgical procedure to treat gastroesophageal reflux disease (GERD) and hiatal hernia. In a fundoplication, the gastric fundus (upper part) of the stomach is wrapped, or plicated, around the lower end of the esophagus and stitched in place, reinforcing the closing function of the lower esophageal sphincter. The esophageal hiatus is also narrowed down by sutures to prevent or treat concurrent hiatal hernia, in which the fundus slides up through the enlarged esophageal hiatus of the diaphragm.

In a Nissen fundoplication, also called a complete fundoplication, the fundus is wrapped the entire 360 degrees around the esophagus. In contrast, surgery for achalasia is generally accompanied by either a Dor or Toupet partial fundoplication, which is less likely than a Nissen wrap to aggravate the dysphagia that characterizes achalasia. In a Dor (anterior) fundoplication, the fundus is laid over the top of the esophagus; while in a Toupet (posterior) fundoplication, the fundus is wrapped around the back of the esophagus.

The procedure is now routinely performed laparoscopically. When used to alleviate gastroesophageal reflux symptoms in patients with delayed gastric emptying (gastroparesis), it is frequently combined with modification of the pylorus via pyloromyotomy or pyloroplasty. (You can read that here in another blog article of mine: There is also a new Facebook support group for those who have had it done, and also combat Gastroparesis: GASTROPARESIS AFTER BARIATRIC SURGERY.

This is a completed Nissen Fundoplication in Watercolors:
Source: By Dana Hamers - Own work, CC BY-SA 3.0,

This is the Nissen Fundoplication Procedure:
Source: Original Artwork by James P. Gray, M.D. 2007 (author)

The doctor that I saw that the Mayo Clinic wanted me to have this surgery done so that it would stop my vomiting. However, he concluded that since I vomit so violently, I would undo the surgery. A mom who reads my blog and has a son with gastroparesis, was nice enough to share his story with me about the Nissen he had done. When my doctor said that it would stop vomiting, he was wrong. His story is below,

"Hi, my 17 year old son had the Nissen procedure last year. He too violently throws up. The surgery went well but he said out of his 33 surgeries it was the most painful after. He went through the recovery process not realizing until about a week after that he could not even swallow water without it coming right back up.

He lost weight quickly and was very dehydrated so at his check up appointment the hospitalized him. The Nissen was too tight and nothing was going to his stomach. The doctor did a scope and stretched the area. That helped for a bit but they had to go back and stretch it a second time.

That was the last stretch they had to do. They said the Nissen would make it almost impossible for him to throw up. Boy were they wrong. He still throws up most every time he eats. By the way he has GP (gastroparesis) and has an electric stimulator in his stomach. Amanda S."

I also know a few people with gastroparesis who have had this surgery done and they are miserable now. They are unable to vomit at all. That worries me, personally, because what if you get food poisoning and need to vomit to get it out? What do you do then?

"Gastroparesis Following Nissen Fundoplication And Hiatal Hernia Repair

Nissen fundoplication with hiatal hernia repair is the most reliable and most effective treatment of GERD or acid reflux disease. The procedure is also very safe with less than 1% complication rate. Gastroparesis or delayed gastric emptying is a poorly understood medical disorder. Gastroparesis results from abnormal gastro-duodenal motility resulting in nausea, vomiting, bloating, epigastric pain and early satiety. Gastroparesis can also contribute to acid reflux disease. GERD is a multi-factorial problem and is closely related to gastric motility. Indeed, gastric fundus compliance, relaxation, food accommodation and luminal pressure affects transient lower esophageal sphincter relaxation, TLESR. TLESR is believed to be the main cause of acid reflux. It is not surprising for gastroparesis patients to suffer from heartburn and other GERD related symptoms. In fact, both GERD and gastroparesis may represent different aspects of the same problem related to esophago-gastro-intestinal dysmotility.

Many GERD patients undergoing Nissen fundoplication and hiatal hernia repair surgery may also have undiagnosed gastroparesis. Around 40% of GERD patients suffer from delayed gastric emptying. Nissen fundoplication increases gastric emptying and is sometimes associated with dumping especially in children. Wrapping the fundus around the esophagus decreases gastric compliance possibly leading to increased gastric emptying. The same mechanism of action may also be at play in the case of sleeve gastrectomy. By resecting the gastric fundus, gastric compliance decreases and emptying increases. Consequently, Nissen surgery improves gastric emptying and it contributes to gastroparesis symptom resolution.

In a minority of patients, Nissen surgery is associated with post-operative gastroparesis symptom development. These patients develop nausea, bloating, and pain in the first few days after Nissen surgery. It is unclear whether the surgery itself causes de novo gastroparesis or if it exacerbates an already existing problem with gastric emptying. It has always been assumed that vagal nerve injury results in gastric stasis and failure of the pylorus to relax. Pyloromyotomy has also been advocated in vagotomy cases. Swanstrom et al published a study in 2009 in Archives of Surgery titled “Outcomes of Nissen Fundoplication in Patients with Gastroesophageal Reflux Disease and Delayed Gastric Emptying”. He recommends the addition of pyloroplasty to Nissen fundoplication in cases of delayed gastric emptying. In my experience, pyloromyotomy, like other drainage procedures, has minimal effect on gastric emptying. Gastric emptying is a highly coordinated myo-electrical process. Many feedback signals, in addition to the vagus nerve, modulate this activity. It is unlikely that post-operative gastroparesis is the sole result of vagal nerve injury.

In 2004, a study published by Masclee et al, in the Annals of Surgery showed that laparoscopic fundoplication increases gastric emptying independent of vagal nerve function. The authors nicely showed that 10% of fundoplication patients developed vagal nerve dysfunction post-operatively without affecting gastric emptying or the efficacy of fundoplication in controlling acid reflux. The etiology of gastric stasis is following Nissen surgery remains unclear. There are no established treatment guidelines for gastroparesis. Medications, gastric pacing and drainage procedures are not effective solutions. Subtotal gastrectomy and gastric bypass are associated with poor outcomes. Longitudinal gastrectomy with or without duodeno-jejunostomy seems to be very effective in curing gastroparesis. I have developed this technique several years ago and I have had the chance to apply it on 4 patients so far. Last year, a young man with gastroparesis following fundoplication surgery at an outside institution presented to my office. I performed a longitudinal gastrectomy while preserving the fundoplication and antrum. His symptoms improved immediately. A post-operative UGI study on day one after surgery showed normal gastric emptying. The patient is 8-month post-op now and still doing great.

In summary, gastroparesis and gastric emptying remain poorly understood. However, a tailored longitudinal gastrectomy, even in the presence of a fundoplication, may be an effective and durable solution for gastroparesis. Additional studies are needed to establish this approach as the standard of care treatment for gastroparesis."


WebMD says,

"Surgery Overview

During fundoplication surgery, the upper curve of the stomach (the fundus) is wrapped around the esophagus camera and sewn into place so that the lower portion of the esophagus passes through a small tunnel of stomach muscle. This surgery strengthens the valve between the esophagus and stomach (lower esophageal sphincter), which stops acid from backing up into the esophagus as easily. This allows the esophagus to heal.

This procedure can be done through the abdomen or the chest. The chest approach is often used if a person is overweight or has a short esophagus.

This procedure is often done using a laparoscopic surgical technique. Outcomes of the laparoscopic technique are best when the surgery is done by a surgeon with experience using this procedure.

If a person has a hiatal hernia, which can cause gastroesophageal reflux disease (GERD) camera.gif symptoms, it will also be repaired during this surgery.

What To Expect After Surgery

If open surgery (which requires a large incision) is done, you will most likely spend several days in the hospital. A general anesthetic is used, which means you sleep through the operation. After open surgery, you may need 4 to 6 weeks to get back to work or your normal routine.

If the laparoscopic method is used, you will most likely be in the hospital for only 2 to 3 days. A general anesthetic is used. You will have less pain after surgery, because there is no large incision to heal. After laparoscopic surgery, most people can go back to work or their normal routine in about 2 to 3 weeks, depending on their work.

After either surgery, you may need to change the way you eat. You may need to eat only soft foods until the surgery heals. And you should chew food thoroughly and eat more slowly to give the food time to go down the esophagus.

Why It Is Done

Fundoplication surgery is most often used to treat GERD symptoms that are likely to be caused in part by a hiatal hernia and that have not been well controlled by medicines. The surgery may also be used for some people who do not have a hiatal hernia. Surgery also may be an option when:

Treatment with medicines does not completely relieve your symptoms, and the remaining symptoms are proved to be caused by reflux of stomach juices.

You do not want or, because of side effects, you are unable to take medicines over an extended period of time to control your GERD symptoms, and you are willing to accept the risks of surgery.

You have symptoms that do not adequately improve when treated with medicines. Examples of these symptoms are asthma, hoarseness, or cough along with reflux.

How Well It Works

In most people who have laparoscopic surgery for GERD, the surgery improves symptoms and heals the damage done to the esophagus.

Over time, some people have symptoms come back, have esophagitis come back, need to take medicine for symptoms, or need another operation.

Surgery can cause new and troublesome symptoms. Over time, some people have trouble swallowing, have increased flatulence (gas), and/or have trouble belching.

Risks or complications following fundoplication surgery include:

Difficulty swallowing because the stomach is wrapped too high on the esophagus or is wrapped too tightly.

The esophagus sliding out of the wrapped portion of the stomach so that the valve (lower esophageal sphincter) is no longer supported.
Heartburn that comes back.

Bloating and discomfort from gas buildup because the person is not able to burp.

Excess gas.

Risks of anesthesia.

Risks of major surgery (infection or bleeding).

For some people, the side effects of surgery-bloating caused by gas buildup, swallowing problems, pain at the surgical site-are as bothersome as GERD symptoms. The fundoplication procedure cannot be reversed, and in some cases it may not be possible to relieve the symptoms of these complications, even with a second surgery.

What To Think About

GERD can be annoying and even painful. But it is not a dangerous disease. For any GERD treatment to be worth trying, it needs to be very safe. For many people, especially those who have few problems taking medicine, surgery is not a good choice.

But when fundoplication surgery is successful, it may end the need for long-term treatment with medicine. When you are deciding between surgery and treatment with medicine, weigh the cost, risks, and potential complications of the surgery against the cost and inconvenience of taking medicine.

GERD: Which Treatment Should I Use?

Before surgery, additional tests will usually be done to be sure that surgery is likely to help cure GERD symptoms and to diagnose problems that could be made worse by surgery.

Second surgeries are harder to do, are less successful, and are more risky. So it is extremely important that the first procedure be considered carefully and be done by an experienced surgeon who is more likely to be successful the first time.

Surgery to treat GERD is rarely done on people who:

Are older adults, especially if they have other health problems in addition to GERD.

Have weak squeezing motions (peristalsis) in the esophagus. These motions are important to move food down the esophagus to the stomach. Surgery may make this problem worse, causing food to get stuck in the esophagus.

Have unusual symptoms that might be made worse by surgery.

In special cases, other surgeries such as partial fundoplication or gastropexy may be done instead of fundoplication surgery.


References and Citations:

Lundell L, et al. (2007). Seven-year follow-up of a randomized clinical trial comparing proton-pump inhibition with surgical therapy for reflux oesophagitis. British Journal of Surgery, 94(2): 198-203.

Other Works Consulted:

Galmiche J-P, et al. (2011). Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD. JAMA, 305(19): 1969-1977.


By: Healthwise Staff
Primary Medical ReviewerAdam Husney, MD - Family Medicine
Specialist Medical ReviewerPeter J. Kahrilas, MD - Gastroenterology

Current as of November 20, 2015"

Monday, June 5, 2017

Pyloric Stent & Pyloroplasty

Pyloroplasty is surgery to widen the opening in the lower part of the stomach (pylorus) so that stomach contents can empty into the small intestine (duodenum). It is used for treatment for gastroparesis. A pyloric stent is used as a bridge between the stomach and the small intestine.


"The pylorus is a thick, muscular area. When it thickens, food cannot pass through. The surgery is done while you are under general anesthesia (asleep and pain-free).

If you have open surgery, the surgeon:

Makes a large surgical cut in your belly to open the area.

Cuts through some of the thickened muscle so it becomes wider.

Closes the cut in a way that keeps the pylorus open. This allows the stomach to empty.

Surgeons can also do this surgery using a laparoscope. A laparoscope is a tiny camera that is inserted into your belly through a small cut. Video from the camera will appear on a monitor in the operating room. The surgeon views the monitor to do the surgery. During the surgery:

Three to five small cuts are made in your belly. The camera and other small tools will be inserted through these cuts. Your belly will be filled with gas to allow the surgeon to see the area and perform the surgery with more room to work.The pylorus is operated on as described above.

Why the Procedure is Performed
Pyloroplasty is used to treat complications in people with peptic ulcers or other stomach problems that cause a blockage of the stomach opening.

Risks for anesthesia and surgery in general are:
Reactions to medications
breathing problems
blood clots

Risks for this surgery include:
Damage to the intestine
Leakage of stomach contents
Long-term diarrhea
Tear in the lining of nearby organs (mucosal perforation)

Before the procedure, tell your surgeon:
If you are or could be pregnant
What medicines you're taking, including medicines, supplements, or herbs you bought without a prescription

During the days before your surgery:
You may be asked to stop taking medicines that make it hard for your blood to clot. Some of these are aspirin, ibuprofen (Advil, Motrin), vitamin E, warfarin (Coumadin), and clopidogrel (Plavix).
Ask your surgeon which drugs you should still take on the day of the surgery.
If you smoke, try to stop. Ask your surgeon for help quitting.

On the day of your surgery:
Follow instructions about not eating and drinking.
Take the medicines your surgeon told you to take with a small sip of water.
Arrive at the hospital on time.
After the Procedure
After surgery, the health care team will monitor your breathing, blood pressure, temperature, and heart rate. Most people can go home within 24 hours.

Outlook (Prognosis):
Most people recover quickly and completely. The average hospital stay is 2 to 3 days. Most people can slowly begin a regular diet in a few weeks.

Alternative Names
Peptic ulcer - pyloroplasty; PUD - pyloroplasty; Pyloric obstruction - pyloroplasty

References: Chan FKL, Lau JYW. Peptic ulcer disease. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. 10th ed. Philadelphia, PA: Elsevier Saunders; 2016:chap 53.

Teitelbaum EN, Hungness ES, Mahvi DM. Stomach. In: Townsend CM, Beauchamp RD, Evers BM, Mattox KL, eds. Sabiston Textbook of Surgery. 20th ed. Philadelphia, PA: Elsevier; 2017:chap 48."


"Gastroparesis: Looking at a Breakthrough

John Clarke says that a stent to bridge the stomach and small intestine may play a big role in treating patients with gastroparesis in the future.

Patients with gastroparesis don’t get a lot of good news from their physicians. Risky medications or gastric surgery have typically been the go-to solutions for people whose stomachs don’t empty properly.

Those less-than-ideal options prodded gastrointestinal motility specialist John Clarke and colleagues to a new approach: Rather than cut the pyloric valve, why not insert a stent to bridge the stomach and small intestine?

Now, results from three stent placements are promising. The write-up is soon to be published in the journal Endoscopy.

'I think this technique could potentially play a big role in the treatment of gastroparesis,' says Clarke, clinical director of the Johns Hopkins Center for Neurogastroenterology.

All of the patients that Clarke describes showed dramatic reductions in symptoms. A 15-year-old boy with chronic nausea and vomiting, for example, had endured unsuccessful trials of erythromycin, metoclopramide, domperidone and promethazine. He showed significant improvement after undergoing transpyloric stent placement. A 54-year-old man with idiopathic gastroparesis who also didn’t respond to medication experienced a complete recovery.

A third patient had minor complications that were remedied with relative ease. 'Her stent migrated out and her pain came back,' says Clarke. Things were once again fine after the team repositioned the stent.

Technically, stent placement is pretty simple, says Clarke, and the risk appears to be minimal. 'If it doesn’t work, you just take it out,' he says. 'And, as opposed to gastric stimulation, which is done through surgery, this is just endoscopy. Although this sounds a bit unconventional, its safety looks better than anything else we have.'

Clarke explains that advances in stent technology played a key role in his team’s decision to move ahead with the pyloric stents.

Recently, the field’s seen creation of a flexible, covered stent 'that you can place via the endoscope,' Clarke says. 'The stent is metallic, but covered with a silicone lining so that the mucosa won’t grow into it. The stent was approved to treat obstructions, but hadn’t yet been used to treat gastroparesis.'

The number of patients with a gastroparesis diagnosis is on the rise, Clarke says. 'I’d estimate that 30 percent of my clinical practice comprises patients with gastroparesis. And only about 30 percent of them are diabetic. Most of the patients I see have idiopathic disease.'

In the next few months Clarke expects to begin a larger trial of the stent placement.

'This is an experimental therapy, and the long-term benefits are unclear,' he explains. 'However, given the few options currently available and the risk associated with those options, endoscopic stent placement may have a key role to play in managing this complex disorder.'”

The pyloric stent is used to stretch out the pylorus so that food can pass through easier. Sometimes, balloons may be used to help stretch it out and to help spasms. The video below goes into detail about it.

"Johns Hopkins GI Doctors Use Endoscopy to Place Transpyloric Stent 'Could Play a Big Role' in Gastroparesis Treatment

Physicians at Johns Hopkins say they are encouraged by early results in three patients of their new treatment for gastroparesis, a condition marked by the failure of the stomach to properly empty its contents into the small intestine. In an article published online today in the journal Endoscopy, they describe how the placement of a small metal stent in the stomach can improve life for people who suffer from severe bouts of nausea, abdominal pain and vomiting that accompany the condition.

John Clarke, M.D., assistant professor of medicine at the Johns Hopkins University School of Medicine, and the article’s lead author, used an endoscope to place a pyloric stent in three patients with delayed gastric emptying. The pylorus is the part of the stomach that connects to the small bowel.

'I think this new technique could play a big role in the treatment of gastroparesis,' says Clarke, who also is clinical director of the Johns Hopkins Center for Neurogastroenterology. 'Though it sounds a little bit unconventional, the safety of it may be better than anything else we have out there.'

Clarke says recently developed flexible, silicone-covered metal stents have already been approved to treat some gastrointestinal obstructions, but until now have not been used to treat gastroparesis.

Typically, patients with gastroparesis don’t get a lot of good news from their physicians. Stomach surgery or risky medications such as erythromycin and metoclopramide have been the go-to treatments for the condition, which can have serious health and quality-of-life consequences.

'There are few FDA-approved options for gastroparesis patients,' Clarke says. 'The only medicines that are approved have a number of adverse effects associated with them.'

The National Institutes of Health estimates that 5 million Americans live with gastroparesis, a condition in which the contents of the stomach empty into the intestine slowly or not at all. Symptoms, including reflux, become chronic.

Using an endoscope, Clarke placed a self-expandable, coated metallic stent across the three patients’ pyloric channels, holding the channels open and allowing the patients’ stomachs to empty normally.

All three patients showed dramatic reductions in symptoms, Clarke says. One was a 15-year-old boy with chronic nausea and vomiting who had endured unsuccessful trials of erythromycin, metoclopramide, domperidone and promethazine. A second was a 54-year-old man with idiopathic gastroparesis who also didn't respond to medication, but had complete recovery after his stent placement. In a third patient, the stent migrated out of place and her pain came back, but after replacing it, the pain eased, Clarke reports. All were treated at The Johns Hopkins Hospital.

Clarke says the stent placement procedure isn't difficult.

'Technically it’s pretty simple, and the risk appears to be minimal; if it doesn’t work, you just take it out,' he says. 'Gastric surgery to stimulate emptying is riskier than endoscopy.'

The number of patients diagnosed with gastroparesis is on the rise, Clarke says. 'I’d estimate that 30 percent of my clinical practice comprises patients with gastroparesis.'

Clarke says a larger clinical trial, which he expects to begin in the near future, is needed to provide longer follow-up of results and to identify which patients are likely to benefit the most from stents. “Our hope is that stent placement may become either a primary treatment option or a bridge technology to determine who can best benefit from surgery to improve stomach emptying.”

Endoscopic Treatment of Gastroparesis
Thomas R McCarty and Tarun Rustagi

Gastroparesis has traditionally been a largely medically managed disease with refractory symptoms typically falling under the umbrella of the surgical domain. Surgical options include, but are not limited to, gastrostomy, jejunostomy, pyloromyotomy, or pyloroplasty, and the Food and Drug Administration approved gastric electrical stimulation implantation. Endoscopic management of gastroparesis most commonly involves intrapyloric botulinum toxin injection; however, there exists a variety of endoscopic approaches on the horizon that have the potential to radically shift standard of care. Endoscopic management of gastroparesis seeks to treat delayed gastric emptying with a less invasive approach compared to the surgical approach. This review will serve to highlight such innovative and potentially transformative, endoscopic interventions available to gastroenterologists in the management of gastroparesis.

Keywords: Botulinum, Gastrojejunostomy, Transpyloric, Pyloromyotomy, Gastric stimulator, Gastric pacemaker, Stenting
Core tip: Although a majority of gastroparesis patients respond to medical treatment, patients with refractory symptoms pose a therapeutic challenge and are often referred for surgical management. Endoscopic management of gastroparesis seeks to treat delayed gastric emptying with a less invasive approach compared to the surgical approach. Endoscopic treatment of gastroparesis most commonly involves intrapyloric botulinum toxin injection; however, there exists a variety of endoscopic approaches on the horizon that have the potential to radically shift the standard of care for refractory patients.

Gastric emptying is a highly regulated, carefully choreographed process that demands a harmony of synchronized impulses working together as an impetus for which food can be delivered distally down the gastrointestinal tract. These propulsive forces are generated by proximal fundic tone, the interstitial cells of Cajal, distal antral contractions, and relaxation of the pyloric sphincter to create a scripted peristalsis[1]. Gastroparesis, or delayed gastric emptying, is characterized by physiologic disturbances in antral hypomotility, increased gastric outlet resistance, and pyloric dysfunction without evidence of obstruction[2,3]. Patients typically present with dyspepsia-like symptoms including early satiety, postprandial fullness, bloating, nausea, vomiting, and abdominal pain[2,4-6]. The most common etiologies of gastroparesis are idiopathic, diabetic, or post-surgical[2,7].

The epidemiology of gastroparesis is not well known though a small population-based study showed a prevalence in men and women of 9.6 and 37.8 per 100000 persons and an age-adjusted incidence of 2.4 and 9.8 per 100000 person-years, respectively[8]. Gastric-emptying scintigraphy is the gold standard for the diagnosis of gastroparesis and consensus recommendations for the procedure involve 99-m technetium sulfur-colloid labeled low fat, egg-white meal with imaging at 0, 1, 2, and 4 h[9]. The diagnosis of delayed gastric emptying is confirmed if there is > 90% gastric retention at 1 h, > 60% at 2 h, > 10% at 4 h[9,10]. Small, frequent meals along with medical therapy including prokinetic agents, such as dopaminergic (D2) antagonists - metoclopramide and domperidone, or motilin-analogue - erythromycin, are the first line of treatment.

The majority of data regarding the efficacy of conventional prokinetic agents for the treatment of gastroparesis is outdated[11-15]. It has been approximately 30 years since the first randomized controlled trials of the conventional prokinetic agents, metoclopramide, domperidone, and erythromycin, have been published, and despite this, they are still first-line agents for the treatment of gastroparesis[16]. Metoclopramide has been the most extensively studied and has been associated with less improvement in gastric emptying when compared to erythromycin[15]. A meta-analysis assessing benefits of four different drugs in 514 patients in 36 clinical trials reported the macrolide antibiotic erythromycin as the most potent stimulant of gastric emptying, while erythromycin and the dopamine receptor antagonist domperidone (not available in the United States) are best at reducing symptoms of gastroparesis[17]. Currently, several novel pharmacotherapies such as ghrelin receptor agonists (TZP-101, TZP-102, RM-131), mitemcinal, prucalopride, velusetrag, levosulpiride are in development, though their clinical efficacy and safety remains to be established[16,18,19]. While it is generally accepted that a significant percentage of patients require additional therapy beyond prokinetic agents, no clear data exists to determine the percentage of patients who fail medical management.

Patients with symptoms refractory to medical therapy pose a therapeutic dilemma. Patients are often referred for surgical treatment including a variety of potential procedures not limited to gastrostomy, jejunostomy, pyloromyotomy, pyloroplasty, and gastrectomy to improve gastric emptying. Poor and sometimes unpredictable response, in addition to the morbidity and mortality of surgical interventions, has led to the emergence of endoscopic therapies in management of gastroparesis (Table ​(Table1).1). While frequently under-utilized, endoscopic treatment strategies are at the cusp of altering traditional standard of care with exciting new developments that have the potential to radically shift the preferred management of refractory gastroparesis.

Endoscopic intrapyloric botulinum toxin injection (IPBI) is the most studied and perhaps the most commonly employed endoscopic treatment for those suffering from refractory gastroparesis, though this therapy still remains highly controversial. Botulinum toxin is a potent inhibitor of neuromuscular transmission used more commonly for the treatment of spasm in gastrointestinal sphincters. Botulinum toxin injection into the lower esophageal sphincter (LES), with or without endoscopic ultrasound (EUS)-guidance, is an established safe and effective therapy for management of achalasia in high-risk surgical patients. Low dose injection of botulinum toxin in the pylorus muscle decreases contractility secondary to decreased acetylcholine release by irreversibly binding to cholinergic receptors and directly affects muscle tone at higher doses[20]. The toxin also reduces substance P immuno-reactivity and disrupts pyloric myoelectric activity[21,22].

The procedure involves endoscopic access to the patient’s pylorus with injection typically in a radial pattern at or within 2 cm of the pylorus, with a total dose of 100 to 200 units[23]. There is an alternative hypothesis that antroduodenal or pyloroduodenal manometry may be helpful to evaluate the baseline pylorus muscle tone to determine the best site for IPBI to predict response; however, this warrants further investigation[24]. The usual duration of benefit from IPBI ranges from 1 to 5 mo at which time worsening symptoms can be re-treated with repeated injections[23,25]. It is important to note however, that the effect of IPBI may not be limited simply to the pyloric muscle as there have been rare reports of gastric and intestinal absorption leading to peripheral neuromuscular blockade[26]. Despite this, the procedure is typically well tolerated and safe. There are a multitude of open-label studies in adults with gastroparesis (regardless of cause - idiopathic, diabetic, and post-surgical) reporting an improvement in symptoms and gastric emptying after endoscopic IPBI[25,27-31]. The largest observational study including 63 patients by Bromer et al[25] documented a 43% response rate to botulinum toxin treatment lasting a mean of approximately 5 mo.

While observational data suggests that botulinum toxin injections reduce symptoms and accelerate gastric emptying in both idiopathic and diabetic gastroparesis, 2 independent, double-blinded, randomized controlled studies have shown little to no improvement in gastric emptying and no symptomatic improvement compared with placebo[32]. Friedenberg et al[33], using a randomized, double-blind, placebo-controlled trial, explored whether botulinum toxin improves symptoms to a significantly greater extent than placebo. In this study, 32 patients were randomized to botulinum toxin or placebo with 1-mo follow-up post endoscopic procedure measuring gastric retention at 2 and 4 h and symptoms based upon 2 validated scoring systems - the Gastroparesis Cardinal Symptom Index (GCSI) and the Gastroparesis Visual Analog Scale (GVAS). While endoscopic botulinum toxin injection did improve gastric emptying rates, the benefit was not superior to placebo at 1 mo (67% vs 64% at 2 h, P = 0.56 and 29% vs 28% at 4 h, P = 0.86, for IPBI vs placebo respectively). Additionally, there was no significant difference or improvement of symptoms between IPBI compared to the placebo (GCSI - 34.4 vs 36.4, P = 0.21; GVAS - 603 vs 584, P = 0.68, respectively). Another randomized-controlled crossover study including 23 patients, predominantly with idiopathic gastroparesis, also reported similar results, with no significant benefit of endoscopic injection of botulinum toxin over placebo in improving either symptoms or rate of gastric emptying[34].

This discrepancy between open-label and randomized controlled studies may be related to dose of toxin injected and patient population selected. In a retrospective cohort study of 179 patients by Coleski et al[23], patients treated with 200 units achieved a greater improvement in gastroparetic symptoms 1 to 4 mo post intervention compared to those treated with 100 units (76.7% vs 54.2%, P = 0.02). On multivariate analysis female gender, age < 50 years, and a non-diabetic or post-surgical etiology of gastroparesis were found to be associated with a significant response to therapy in this study. While the use of botulinum toxin remains highly controversial, the American Gastroenterological Association (AGA) currently does not recommend the use of endoscopic IPBI for patients with gastroparesis[35]. However, given the small sample size of existing studies with conflicting data, there is an eminent need for larger randomized trials in the future before a definitive decision or treatment guidelines can be concluded.

In 2000, gastric electrical stimulation (GES) was approved by the United States Food and Drug Administration (FDA) as a humanitarian device exemption in patients with refractory symptoms of diabetic or idiopathic gastroparesis[36]. Often referred to as a gastric pacer, GES uses an implantable device consisting of a pulse generator that allows for electrical stimulation at a variety of frequencies. Permanent GES for gastroparesis, typically 6 cm x 5.5 cm x 1 cm, requires a lengthy surgical implantation under general anesthesia. Several case series and small randomized controlled trials, the most important being the Worldwide Anti-Vomiting Electrical Stimulation Study (WAVESS), have shown clinical benefit from GES[37-43]. A subsequent meta-analysis by Chu et al[44] in 2012 confirmed significant improvement in symptom severity and gastric emptying times, though many of the analyzed studies were low quality observational studies lacking control groups. A more recent study by McCallum et al[40] also demonstrated improvement in weekly vomiting frequency amongst all patients with idiopathic gastroparesis with a median reduction of 61.2%. The National Institute of Health and Care Excellence issued guidelines in 2014 that stated current evidence is adequate to support the use of GES[45].

As of 2012, surgery was the only means available to implant the GES device. Although endoscopic placement of temporary gastric stimulators has been proven as a concept and is often used to determine whether a patient will respond to GES before undergoing a permanent implant surgery, the lack of a permanent endoscopic solution and the reliance on future surgery for symptomatic improvement has limited further endoscopic utilization at present[46,47]. However, Deb et al[48] has designed 5 innovative endoscopic gastric implantation techniques and developed a novel, wirelessly powered miniature gastrostimulator. While this early model was conducted in pig studies with no human data or patient trials, the study provides an important prototype for other dysmotility treatment paradigms and provides exciting new options that may translate in the future to less invasive endoscopic placement in gastroparetic patients. This miniature wireless GES device for endoscopic implantation can be easily inserted into the stomach through an over-tube with 2 GES electrodes endoscopically attached to the gastric mucosa and secured with endoclips[49]. Electro-gastrogram recordings have demonstrated that gastric slow waves become more regular with constant amplitudes when stomach tissues are stimulated, in comparison with no stimulation. The frequency-to-amplitude ratio also changes significantly with stimulation[49].

The miniature gastrostimulator and its attachment techniques have the potential to fundamentally shift the approach to refractory gastroparesis and provide a means for endoscopic implantation of gastric stimulator. Although further studies are required to prove the efficacy of such device, if shown to be effective, the possibility of FDA approval given a similar precedent set by GES would provide a clear indication for endoscopic management. The endoscopic gastric implantation device and technique may decrease the need for surgical implantation of GES and revolutionize the preferred management of refractory gastroparesis.

A novel approach recently described by Clarke et al[50] at Johns Hopkins involves the use of through-the-scope transpyloric stent placement as a treatment for gastroparesis. In this small case series (n = 3), double-layered, fully-covered Niti-S self-expandable metallic stents (TaeWoong Medical, Seoul, South Korea) were used to successfully improve symptoms of gastroparesis. The procedure entails the placement of a self-expandable stent across the pyloric channel, deployed under endoscopic guidance without fluoroscopy. The stent is then fully deployed in the transpyloric position with its proximal end in the gastric antrum. Case 1 involved a 23-year-old woman with diabetic gastroparesis; case 2, a 15-year-old boy with chronic nausea and vomiting with markedly abnormal gastric emptying study; and case 3, a 45-year-old man with idiopathic gastroparesis. In all 3 cases, patient symptoms markedly improved or became asymptomatic at 115 d, 122 d, and 174 d follow-up respectively. While this includes only a case series of 3 patients, the stark improvement and lasting results at follow-up after the procedure suggest that transpyloric stent placement improves symptoms associated with impaired gastric emptying[50].

A major concern with transpyloric stenting is stent migration leading to recurrence of symptoms. Several stent securing methods such as endoscopic clips [through-the-scope clip (TTSC) and over-the-scope clip (OTSC)] and endoscopic suturing (ES) have been described to reduce stent migration. Despite the numerous options available, the question remains which stent securing method is superior. In a small case series by Saxena et al[51], transpyloric stent placement and fixation was performed in patients with refractory gastropariesis. The stent was anchored to the antral mucosa with either no device, TTSC, OTSC, or ES. A total of 17 patients underwent 28 transpyloric stent placements with 100% success rate regardless of method. Stent migration occurred as expected in 100% of those with no device; however stent migration was significantly lower in the ES vs TTSC group (16.7% vs 100%, P = 0.02). Stent migration occurred more frequently in the OTSC placement group as compared to the ES group (52.9% vs 16.7%, P = 0.075). With this data, albeit limited due to the number of the patients studied, there is evidence for concern regarding stent migration with transpyloric stent placement; however, it appears this can be minimized with OTSC and endoscopic suturing.

Currently, future studies are required to truly ascertain the long-term durability, utility, and preferred method for transpyloric stenting and fixation. Until that time, transpyloric stenting will remain a limited option for endoscopists in the management of patients with refractory gastroparesis.

Rao et al[52] demonstrated that phasic motor activity in the antrum and duodenum can be stimulated by fundic balloon distention. While there are no such studies to determine the effect of pyloric channel distention on the interstitial cells of Cajal in the stomach or gastric emptying, endoscopic pyloromyotomy and manipulation of the pylorus may improve gastroparesis refractory to medical management. With this notion of distention or disruption of the pylorus to improve gastroparetic symptoms, Khashab et al[53] demonstrated the feasibility and efficacy of this approach with a case report of the first human gastric peroral endoscopic myotomy (G-POEM) in a patient with severe refractory gastroparesis. The procedure was well tolerated with vast improvement in gastroparetic symptoms noted at 12-wk follow-up.

This technique is similar in principle to the submucosal dissection and myotomy performed for the treatment of achalasia[54]. Techniques through a submuscoal tunnel were first described in animal models by Pasricha et al[55] in 2007. Endoscopy is performed and involves myotomy of the inner circular and oblique muscle bundles 2-5 cm proximal to the pylorus on the anterior wall of the stomach, preserving the longitudinal muscle layers with larger vessels in the submucosa coagulated. This is then followed by endoscopic pyloromyotomy by dissecting the pylorus until deeper layers become evident with full separation of the pyloric ring[54,56].

In another study by Shlomovitz et al[56], endoscopic pyloromyotomy was performed in 7 female patients with early follow-up suggesting promising symptomatic improvement in 6 of the 7 and normal gastric emptying studies at 4 h noted in 4 of the 5 patients. One patient that did not respond subsequently underwent laproscopic pyloroplasty. Complications included gastrointestinal bleeding in one patient 2 wk after the procedure and pneumonia. Despite these complications, this endoluminal pyloromyotomy technique could provide an incision-less, less invasive alternative with similar functional outcome as compared to standard laparoscopic pyloroplasty[56]. While the small number of cases certainly limits the ability to determine the true impact of this procedure in the management of gastroparesis, with more frequent use, increasing technical experience, and more data, endoscopic pyloromyotomy has exciting potential to be at the forefront in the endoscopic management of gastroparesis.

Enteral nutrition and feeding is sometimes required for more severe symptoms and can be seen in up to 30% of grade 3 gastroparesis[57,58]. Direct percutaneous endoscopic jejunostomy (DPEJ) is a push enteroscopy technique that was first described by Shike et al[59], and offers another approach to provide direct postpyloric enteral nutritional support. Percutaneous endoscopic jejunostomy (PEJ) is a safe and effective means to palliate malnutrition in patients with severe gastroparesis[60,61]. Maple et al[62] demonstrated, in the largest cohort study to date, clinical outcomes with DPEJ and included 307 attempts at PEJ placement with a success rate of 68%. While this study included multiple indications for DPEJ placement, gastroparesis was a substantial proportion (n = 61 or 21%). A case series by Toussaint et al[63], showed a PEJ technical success rate of 78.6% with no immediate complications reported; however, this was based upon a small sample size of 14 patients total. Based on these data, PEJ should be considered in the algorithm of enteral access for nutritional support before jejunostomy is considered.

The main limitation of DPEJ is technical difficulty as the jejunum is narrow, making it more difficult to advance a needle directly into the lumen[64]. This difficulty can be alleviated with balloon-assisted enteroscopy (BAE)[65]. Aktas et al[66] reported the first prospective study in which single-balloon enteroscopy (SBE)-assisted DPEJ was successful in 11 of the 12 procedures (92%). In this prospective case study, SBE was shown to facilitate the identification of an ideal DPEJ insertion site for the placement of a direct percutaneous jejunal feeding tube. While again this study is limited in size, the results were similar to previous small case series using double-balloon enteroscopy (DBE)-assisted DPEJ placement[65,67].

While surgical gastrojejunostomy is a potential treatment option for patients with gastroparesis, the procedure is associated with substantial morbidity and mortality when patients are in less than ideal clinical condition[68-71]. Fritscher-Ravens et al[72,73] and Binmoeller et al[74] first described EUS-guided gastrojejunostomy in pigs by using a compression button and lumen-apposing metal stent, respectively. These studies were built upon the success of previous studies - notably Cope et al[75] creating the first transluminal anastamosis using self-expanding metal stents (SEMS) and Chopita et al[76] reporting the first clinical trial using fully covered version of the flared stent. While the Fritscher-Ravens et al[72,73] and Binmoeller et al[74] studies were performed as possible alternatives to surgical bypass for the palliation of malignant gastric outlet obstruction, more benign conditions such as gastroparesis may potentially benefit from this transluminal therapy.

An additional study performed by Itoi et al[77], developed a new enteric tube that allowed for the entrapment of fluid between the double balloons without the need to use tissue-opposing devices such as tilt tags. This maintains distention of the small bowel between the double balloons at the initial FNA needle puncture site. Although simply a pilot study, all stents, with exception of one stent, were successfully deployed without complication. All animals showed normal eating behavior without signs of infection at 1-mo follow-up post procedure. Endoscopic gastric imaging showed patent stents in all pigs. While this study lacks power, the initial findings are impressive. The development of a EUS-guided gastrojejunostomy appears to be promising as a minimally invasive treatment.

Although surgical gastrojejunostomy has been shown to improve gastroparetic symptoms, EUS-guided gastrojejunostomy warrants further investigation owing to unknown long-term stent safety and patency issues[74]. Ideally, the stent can be removed after an interval of time, leaving a permanent fistula tract. However, studies are needed to determine the necessary pressure gradient and initial gastrojejunostomy tract diameter in order to maintain long-term fistula patency after stent removal. The minute amount of data available to date, while optimistic and potentially transformative, requires repeat analysis and trials with human study before implementation into the gastroenterologist’s everyday arsenal. However, given the technical success of studies above, the future of endoscopic gastrojejunostomy using EUS-guided lumen-apposing metal stents is bright with the potential to diminish the need for invasive surgeries and improve symptoms of gastroparesis refractory to medical management.

In summary, there is a wealth of potential endoscopic approaches that may one day be at the disposal of endoscopists. While many of these procedures and pioneering approaches have the potential to be ground-breaking and radically transform the standard management algorithm of refractory gastroparesis, all of them require more studies to validate, corroborate, and substantiate early optimistic data. The opportunities for less invasive endoscopic treatment of gastroparesis are abundant and inspiring. From further studies to evaluate the true effectiveness of IPBI to the potential for EUS-guided lumen-apposing metal stents for gastrojejunostomy, the role of endoscopic therapies in management of gastroparesis is likely to expand in near future."

Sunday, June 4, 2017

GPOEM and/or POP - What is it and How Does it Help?

GPOEM is a new procedure, created at Emory, in order to help normalize gastric emptying. The information about GPOEM can be found below. I'm not entirely familiar with it yet but it seems like a promising treatment. It is also called "POP" surgery. I guess we will see.

"SAN DIEGO — Gastric peroral endoscopic myotomy (G-POEM) can be used to effectively treat the vast majority of patients with gastroparesis refractory to conventional therapy, two new studies show.

Gastroparesis is a chronic, often disabling, disorder that affects about 4% of the population. It can be a complication of diabetes or surgery, but in about one-third of cases, it is idiopathic. Medical treatment frequently fails.

G-POEM is modeled on the natural orifice endoscopic POEM for the treatment of achalasia. The procedural principles of the two techniques — such as mucosal entry, tunneling, myotomy (including pyloromyotomy), and closure of mucosal entry — are similar.

Results from the first study, on 30 patients with gastroparesis treated with G-POEM, were presented here at Digestive Disease Week 2016 by Mouen Khashab, MD, from the Johns Hopkins Hospital in Baltimore.

All 30 patients had symptoms refractory to medical therapy, including onabotulinumtoxinA (Botox) injection and transpyloric stenting. Nausea and vomiting affected 25 (83%) patients, weight loss affected 27 (90%) patients (average loss, 10% of body weight), and delayed gastric emptying affected 11 (37%) patients.

Response Rate Exceeds 85% in Two Early Studies

For the 30 patients, mean duration of the G-POEM procedure was 72 minutes, and mean hospital stay was 3.3 days.

At mean follow-up of 5.5 months (range, 3.0 - 30.0 months), 26 (86%) patients had achieved a clinical response, defined as improvement in gastroparetic symptoms without recurrent hospitalization. Of the four patients who did not respond to G-POEM, two had diabetes, one had gastroparesis of idiopathic origin, and one was postsurgical.

"These responses were sustained, and there were no further hospitalizations," Dr Khashab reported.

Of the 17 patients who underwent repeat gastroesophageal scintigraphy, eight (47%) showed normalization of gastric emptying and six (35%) showed improvement.

'G-POEM concomitantly results in normalization of gastric emptying in a significant proportion of treated patients,' he said.

Adverse events occurred in two (6.7%) patients: one developed pneumoperitoneum and the other developed prepyloric ulcer.

'We had two minor complications, but these 30 procedures were performed by very experienced endoscopists at tertiary centers,' he explained. 'G-POEM is more technically challenging than esophageal POEM, as the location is more distal.'

On the basis of these 'amazing results,' Dr Khashab told Medscape Medical News, 'we are starting a multicenter prospective trial in the United States, South America, and Asia, recruiting about 50 patients. This will be definitive.'"

"G-POEM Shows Promise for Relieving Gastroparesis Symptoms, Improving QOL (Quality of Life)

LAS VEGAS — The minimally invasive procedure called gastric per oral endoscopic pyloromyotomy, or G-POEM, demonstrated promising short-term outcomes for patients with gastroparesis, according to retrospective data presented at ACG 2016.

'We showed that ... G-POEM is a feasible approach for treating gastroparesis,' Sunil Dacha, MD, from Emory University School of Medicine, said during his presentation. 'There was significant improvement in symptoms in most patients, and we showed an improvement in [Gastroparesis Cardinal Score Index (GCSI)], reduced gastric retention percentages on 4-hour [gastric emptying study (GES)] and significant improvements in quality of life domains.'

Dacha and colleagues reviewed data on 10 patients with refractory gastroparesis who underwent G-POEM (mean age, 47.3 years). Four patients had diabetic gastroparesis, four idiopathic, one post-infectious and one post-surgical. Eight were women, four were black and six were white.

The procedure was successful in all patients with no adverse events, a mean procedural duration of 47.7 minutes, a mean myotomy length of 2.94 cm, and a mean length of stay of 2.5 days.

After a mean follow-up of 4.6 months, eight of the patients achieved clinical success, defined by reduced GCSI scores and no recurrent hospitalization.

Mean GCSI scores dropped from 30.1 to 12.8 in these patients (P = .0001), and GES normalized in five patients and improved in two. Additionally, mean 4-hour gastric retention on GES dropped from 62.5% to 25.4% (P = .009) after the procedure.

Several quality of life domains on the SF-36 questionnaire also improved significantly at follow-up, including bodily pain, general health, vitality, social functioning and mental health.

One of the patients did not respond and was hospitalized for nausea and vomiting 15 days after the procedure, and another did not experience improvement of symptoms.

In the future, 'we need to identify the exact subset of patients that benefit from G-POEM, and we need to standardize the work-up and the procedural techniques as there is no uniform agreement on the procedural techniques at this point,' Dacha said. 'We need to standardize measurement of outcomes, ... long-term outcomes data are needed,' and especially important is 'training the future generation of endoscopists for G-POEM, which is essentially endoscopic surgery rather than an endoscopic procedure.' – by Adam Leitenberger


Dacha S, et al. Abstract #2. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 17-19, 2016; Las Vegas, NV."

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."

Gastric Bypass, the Sleeve, and Gastroparesis

I have seen, recently, in the support groups questions about the gastric bypass, sleeve, etc. I wanted to share with you the year's worth of research that I have been doing so that if you are considering a gastric bypass or a sleeve, you can be well informed. My doctor keeps trying to push a gastric bypass on me, but that is not going to fix the nerve damage to my vagus nerve. Personally, I don't want it because I'm scared it will cause more problems than it's worth. I've had friends pass away from complications due to gastric bypasses. In fact, three days ago when I was in the emergency room, a lady came in who had a gastric bypass done and was vomiting up blood. This is a decision that you will have to make for yourself but I wanted to share the information I've gathered so that you can decide if this is for you. Sources are included below. There are a lot of hoops to jump through in order to get a gastric bypass or sleeve. Each doctor is different on their requirements.

The information below will also go into detail the differences between the bypass and the sleeve. Before you make the decision to have surgery (and I know a lot of you are desperate for relief), make time to talk to support groups with other gastroparesis patients so that they can give you advice. I would also recommend writing down any questions/concerns that you may have for the doctor, lest you forget or the doctor is in such a hurry that you don't have time to think of questions while you're in the doctor's exam room. Be your own advocate. Additionally, I would get a second opinion, just to be on the safe side. You should meet with a nutritionist too, since your diet may be a bit different from others getting a gastric bypass. You and the nutritionist should work together to come up with a plan if you choose to have this surgery. There is also a new Facebook support group for those who have had it done, and also combat Gastroparesis: GASTROPARESIS AFTER BARIATRIC SURGERY.

Roux-en-Y Gastric Bypass:

This surgery is not for everyone, and I've already decided it's not for me...but I hope this research will help you make the right decision for you. Again, if your gastroparesis is caused by vagus nerve damage, removing parts of your stomach may not help. It also will not stop the vomiting.