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Melanie Cole, MS (Host): Today, we're highlighting gastroparesis, identifying symptoms and how precise diagnostic tests and a range of treatment options from dietary changes to advanced surgical solutions can offer relief and improve quality of life. Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole. And joining me today is Dr. Jeffrey Friedman. He's the Director of Metabolic and Bariatric Surgery at the University of Florida College of Medicine. Dr. Friedman, it's a pleasure to have you join us. So, tell the listeners, what is gastroparesis? How common is this?

Dr. Jeffrey Friedman: Hi. Thank you for having me. Gastroparesis is a difficult disease to diagnose. And because of that, it's really unknown the prevalence of gastroparesis. I think that a lot of education needs to go into gastroparesis to help the diagnosis. But gastroparesis is a delay of the stomach emptying, and it can cause symptoms like nausea, vomiting, bloating, abdominal pain, and weight loss. And it can be a very negative thing in patients' lives, especially when the diagnosis is so difficult. And so, part of this today is to hopefully spread some information, and knowledge about the disease that is gastroparesis to help in the diagnosis.

Melanie Cole, MS: Well, thank you. And I'm glad that's exactly what we are doing today is increasing awareness and education. So if contractions are weaker and slower than they would need to be to digest food and that's what causes that pain, and I do know some people with it, is this a motility issue? Is it an immune disorder? Do we know what causes it?

Dr. Jeffrey Friedman: Well, that's a good question. And the answer is sometimes we do, and unfortunately, sometimes we don't. And that can be very frustrating when we don't know the cause. Certainly, diabetes, high blood sugars that are uncontrolled can cause nerve damage, and the nerve damage can slow the muscular contraction of the stomach and can be one of the causes of gastroparesis. There are certain viral infections that can cause gastroparesis. There are certain surgeries that can potentially cause gastroparesis. Surgeries such as anti-reflux surgeries can injure or damage the vagus nerve, and can cause a delayed emptying of the stomach. Sometimes we just don't know what causes it? And then, there are medications that can actually cause the stomach emptying to be delayed.

Melanie Cole, MS: This is so interesting. So, how is it diagnosed? Tell us the symptoms people would first notice. You mentioned nausea and vomiting before. Tell us about some of those symptoms. And many people tend to sort of self-diagnose GI issues. I've seen so many people do that. "Oh, it must be this or that." Is this something that that happens to and the difficulty in diagnosing comes from that?

Dr. Jeffrey Friedman: Well, to diagnose the problem, we really need a gastric emptying study, which is a nuclear medicine test. Typically, patients eat some egg salad that has been labeled with a radionucleotide that will show up on the nuclear medicine test. It's called a 4-hour gastric emptying study, and that will give us an idea of how quickly or slowly the patient's stomach is emptying. Other studies that can help are a swallow study, an upper GI, or an upper endoscopy, which can show the delayed emptying of the stomach or retain food within the stomach. But for insurance coverage for the surgical treatment of gastroparesis, we would need a four-hour gastric emptying study.

Melanie Cole, MS: Okay. So once you know what is going on, let's talk about treatment options and start with conservative measures. So first of all, can lifestyle modifications, complementary therapies, help in managing gastroparesis from dietary changes to, you know, exercise, hydration, whatever it is, is there anything that can help? And then, we'll get into pharmacologic and surgical.

Dr. Jeffrey Friedman: You're absolutely right. The first step in treating gastroparesis is just what you said, diet modification, behavioral modification, and doing some of the things you mentioned, increasing your liquid intake to prevent dehydration, restricting certain foods like fats or plant fiber that can be hard to digest, and going to smaller, more frequent meals instead of larger, less frequent meals. Those are the initial steps in treating the gastroparesis. +

When that doesn't work, then correct, you mentioned medications, and medications are the next line of therapy. Unfortunately, the medications tend to treat the symptoms such as the nausea, the bloating, the pain. There are very few medications that are approved for gastroparesis. And to further complicate that, one of the major medications, which is Reglan, the brand name is Reglan, there are long-term side effects of being on that medication. And while the risk is less than 1%, the other complication that physicians worry about prescribing Reglan in the long-term is tardive dyskinesia. And if that happens, it may not go away with the cessation of the medication. So, there aren't a lot of great medications to treat the gastroparesis with, especially in the long term. And so when these medical therapies and behavioral modification therapies fail to provide symptomatic relief, it causes frustration, depression, patients feel hopeless. And a recent study showed that only 4 percent of gastroparesis patients were satisfied with the current medical treatment options. And so, that's where the gastric pacemaker comes into play.

The gastric pacemaker is a pacemaker that's very similar to the pacemaker for your heart. It's two electrodes that we surgically implant into the wall of the stomach. The electrodes get connected to the battery, and the battery sits under a patient's skin. And the battery sends electric impulses through these wires into the muscular layer of the stomach to get them to contract. And this is the best therapy for gastroparesis available when medical therapy hasn't worked. And the company who makes the gastric pacemaker, Entera, has studies that suggest that up to 90% of patients who have a gastric neurostimulator implanted for gastroparesis have some sort of symptomatic relief.

Now, I say that and I want to emphasize that it's not necessarily going to make the patients how they were before they got this terrible disease, but most patients would agree that any symptomatic relief will improve their quality of life, especially with the nausea. And so, most of our patients are very, very happy with the results from their gastric neurostimulator.

Melanie Cole, MS: Is this a long-term fix? And you mentioned symptom relief, but it doesn't cure the situation, yes?

Dr. Jeffrey Friedman: Correct. It does not cure gastroparesis. The goal of the gastric neurostimulator or the gastric pacemaker is symptomatic relief. And again, there are studies that say that 90% of patients with the gastric neurostimulator receive some symptomatic relief. This combined with behavioral modification and medications can treat the disease that is gastroparesis most efficiently. But you are right, it will not cure the disease.

Melanie Cole, MS: Are there any advancements that you're excited about, Dr. Friedman? Anything that you'd like other providers to know and take away as far as ongoing research in the treatment of gastroparesis?

Dr. Jeffrey Friedman: Yes, there are. And the first thing is that the battery is like any battery. And the more you use it, the quicker it dies. And when it dies, the patients will become symptomatic again, and they need that battery removed and replaced with a new battery. And it's not a major ordeal, but it has to be done in the operating room. The company is working on a rechargeable battery that will not need to be removed and replaced. So, that is a major advancement technologically.

And then, there's a subset of patients who will have all of these symptoms that I'm talking about that are consistent with gastroparesis, but they will have a normal gastric emptying study. And so, there are studies ongoing and some publications that are coming out soon looking at this subset of patients, patients with these symptoms and who sound like they have gastroparesis, but don't have an abnormal gastric emptying study. And the gastric pacemaker seems to have some benefit for these patients as well. And when that indication can get extended, I think that that will provide treatment to patients who don't have that option right now, unfortunately.

In addition, I'd like to add that there was a study recently published in the Journal of the American College of Surgeons entitled, "The Clinical Outcomes of a Large Prospective Series of Gastric Electrical Stimulation Patients Using a Multidisciplinary Protocol." And the results showed that there was statistical significant improvement in both nausea and vomiting symptoms at one year post-op and that these statistically significant improvement in symptoms were maintained at five years post-op demonstrating durability of relief. The study also showed that there was a significant reduction in hospitalizations and medication use after the implantation of the gastric neurostimulator.

Melanie Cole, MS: And a final thought, Dr. Friedman, speak to other providers if they have patients, especially primary care, and patients coming in with some of these complaints, what would you like them to know?

Dr. Jeffrey Friedman: Well, I think that it's a disease that we are seeing more and more commonly. And again, it's hard for me to tell you why, it could be an environmental exposure, it could be a viral thing. It's just I don't know the answer to that. But I think that it's important to listen to these patients and to work them up. And I think that the workup initially is complicated, because I think these patients get worked up for gallbladder disease very commonly because of the pain and the bloating and the nausea. And a lot of our patients, gastroparesis patients, have had their gallbladder removed already. I think a lot of them will have upper endoscopies. And when you see the report from the endoscopy and it has retained food within the stomach, I would think about an upper GI, and a four-hour emptying study, and a referral to a center that does implantations of gastric neurostimulators. It's becoming more and more common. There are plenty of centers around the country that do it. Certainly, we provide, at the University of Florida a multidisciplinary level of care, consisting of not just the surgeons, but the dieticians and psychologists who can help with some of the behavioral modification that goes along with treating the disease.

Melanie Cole, MS: Thank you so much, Dr. Friedman, for joining us today. To learn more about this and other healthcare topics at UF Health Shands Hospital, please visit innovation.ufhealth.org. And to listen to more podcasts from our experts, you can always visit ufhealth.org/medmatters. That concludes today's episode of UF Health Med EdCast with UF Health Shands Hospital. I'm Melanie Cole. Thanks so much for joining us today.