Panel discussion and Q&A session VII: Gastroenterology

Prof. Paul Moayyedi, Prof. Irene Sarosiek, Prof. Ian Gralnek, Prof. Pere Gines

Recorded at the 6th McMaster International Review Course in Internal Medicine.
All lectures available at the MIRCIM virtual platform, click here to buy access.

Professor Paul Moayyedi: Welcome everyone to this question and answer session. From the gastroenterology session that we had on Tuesday, a superb session with fantastic speakers and with me today I have those speakers. We have Ian Gralnek from Haifa, Israel, Pere Gines from Barcelona, Spain, myself – Paul Moayyedi – from McMaster University in Canada, and Irene Serosiek from El Paso, Texas. So, we have an interesting hour ahead of us, discussing everything from gastroparesis, acute-on-chronic liver failure, over… sorry, difficult-to-find GI bleeding and IBS. So we will start with gastroparesis and Irene. There are a few questions, particularly around what nutrition you recommend for patients with gastroparesis, since obviously eating is often limited. So what diet do you recommend?

Professor Irene Sarosiek: Hello, welcome everyone. I am Doctor Serosiek from El Paso, Texas in the US, and I am working with patients with gastroparesis. And I am very happy actually to see there is an interest related to diet. [In] fact, this is very hard to study. This is a subject which is not very well represented in the literature. As you probably can imagine, to chase after the best solutions [for] how to eat, what to eat, and what is happening with those patients is very difficult. Any studies which you do in a clinical arena on diet usually fail because patients don't remember, they don't stick with a diet. It's very hard to measure how much they eat, what they eat, and so forth. So that's why we are all limping with this information and we have to make sure we all are a bit more familiar with what gastroparesis requires. I included one slide, a very busy slide, into my presentation and I think that triggered the question, actually, [of] what to eat and what not to eat. So what is important is to actually keep some steps which are important to follow for the patients, because obviously, a condition which is related to the delayed emptying of the stomach – when the stomach is always full of food which is not digested and stays there for a while and cannot be pushed into the lower intestine because of problems with pylorus or any other etiology – is an issue which has to be addressed with a very special rhythm and rhyme of eating. And that's the first step to help with symptoms. Small portions – what is a small portion? A small portion is just eating probably like 1 or 2 cups of food per meal. But if you eat such a small amount of food, you can eat more frequently, and that's something that we suggest for patients. Just eat 6 times a day instead of 2 times a day; don't have breakfast, lunch, and dinner, [but] snack in between and have food available everywhere and then you can actually munch on those things and get calories from it, because, obviously, malnutrition or weight loss is one of the complications of gastroparesis. So, small portions, eating more often, anything that you feel is good for diabetics based on their diabetes diet, then including stuff which can help you out by not making many mistakes. It's not a very good situation [if] patients lie down and eat; they are very sick, they are debilitated, and they are nauseated, so sometimes they eat even lying down in bed or on the couch. That's not a good idea. They have to stand up, they should be actually more mobile. They should not eat very late in the evening before they go to sleep. And those things are important – even though I mentioned in this sense, I cannot tell you how much we stress this [for] our patients. Vitamins and all the nutrients which can be predicted and added to the diet are very important, also. If it comes to the specifics, we always throw two things in there: [it] is a diet which has to be low in fat and a diet which has to be low in fiber. That's what we suggest. So then you have a dilemma – what is on my plate? Is this good for me or not? And that's [a decision that] has to be made. If you use just the – very simple, maybe – thinking pattern of saying [that] whatever is easy for a child to eat should be easy for me to eat also… because I can have blended food, I can have anything which is pureed, I can have any soups, I can have mashed potatoes, food which you can crush with a fork, … almost like in a flex kind of shape is very good for you. And then, the question when it comes to fruit and vegetables, which we all like to eat, there are more limitations and more things which we have to avoid, especially when you think about fruit. When they have a big pit and they have seeds in them, they are not good for a patient with gastroparesis, like plum or any dried fruit – raisins or prunes – they are not good. Big peaches … are not good either. The skin, when it's thick, like for example on a pear, are not very good. Apples are not good either, but if you prepare applesauce or if you peel off the [skin], if you make smoothies out of those fruits, they are much better for you to take – to digest and to keep down. So everything … in those categories [is not good for these patients]. [Most of the fruit] are good: bananas are good for you, cantaloupes are good for the patients, peaches – again, from a can or from a jar, any fruit which is preserved, which is already processed [is] easier to digest. Oranges are not very good [since] they have to be very well peeled, and the same with mandarins. So, cantaloupes and melons are good, but again, just take small bites and crush them as much as possible before you add them to your diet, because they can be trapped inside the stomach as well. So that's the fruit which you avoid and the fruit which you [can eat]. Unfortunately, like I said, patients make a decision [about] what they like. Sometimes what works for one patient doesn't work for another, so just try and see. No seeds, no pits… excuse me, and nothing with the skin. Puree stuff, smoothies, and sometimes another one which is like shakes with milk and fruit are very good for you – or for your patients, in that case, OK?

Paul Moayyedi: Yes, so that answers one of the questions of the attendees. What about, you say [there are] many fruits you shouldn't eat, but what about fruit smoothies, even from the fruits that you would not recommend? What about if they are in a smoothie?

Irene Sarosiek: [With] smoothies, we recommend almost all of the fruit, you can add [it] there, even kiwi; normally, they have seeds, so you just have to be very careful, but again, [with] most of them, you can then just drain the seeds out, if you take only the juice from them. Because orange juice is OK for you [and] tomato juice is also good for you. But then if you have a problem with heartburn, [then] those juices can exacerbate other symptoms and that's not good for you [either]. So, with smoothies there are no major contraindications. Just be smart – again, try [it and] if it's not a good idea, don't do this again, because it's very patient-specific, [despite] the major rules I mentioned before. So, you can use them as smoothies.

Paul Moayyedi: OK, thanks very much. So, moving on to Ian and difficult-to-diagnose GI [gastrointestinal] bleeding, primarily from the midgut. One of the questions is, obviously MIRCIM serves a global audience, and video capsule endoscopy is primarily available in developed countries – there are many countries where this is difficult to obtain – so what you recommend for those countries after you've done your 2 colonoscopies and your 2 endoscopies?

Professor Ian Gralnek: Thanks, Paul, very much. It's a pleasure to be here. I want to thank the organizers of MIRCIM for inviting me. So really this lecture was focused on what's called obscure overt GI bleeding. So “overt” in this case is defined as patients who have melena or hematochezia that is not able to be localized. So we think that this is coming from the small bowel, which is defined in this situation as anywhere from the ligament of Treitz up to the ileocecal valve. If video capsule endoscopy is not available, then what hopefully may be available, if you really have ongoing bleeding like this, you could try and go to a CTE or an MRE – so computed tomography enterography or magnetic resonance enterography – if that is available. If those tests are not available, you could just go to a regular CT with oral and IV contrast and attempt to image if there is some type of a mass lesion that may be bleeding. It also depends on the age of the patient to a certain extent. In terms of endoscopic evaluation, if there are options – again, this may or may not be available – if you have a pediatric colonoscope, you could use that as a push enteroscope, so to push further down into the small bowel than the gastroscope is able to used. Now, that's not the best answer, but it's better than nothing, because then we are only seeing … maybe about 100 cm or so beyond what we've seen with the gastroscope, something like that. You know, there is, really the gold standard today is being able to use video capsule endoscopy to image the small bowel. Now, if you really don't have anything like that and this is really an ongoing problem, then it's an issue of potentially even talking to your surgeons and doing intraoperative enteroscopy. That can be laparoscopy-assisted or even open, where an enterostomy can be made. And even a pediatric colonoscope or adult colonoscope can be inserted using a sterile over-sleeve and be able to intraoperatively look for a source of the small bowel bleeding. Because of capsule endoscopy and what's really called device-assisted enteroscopy or deep enteroscopy – such as double-balloon or single-balloon enteroscopy, or now there is motorized spiral enteroscopy – we rarely do intraoperative enteroscopy anymore. But those are really the options that are there if you don't have video capsule.

Paul Moayyedi: So what about technetium-labeled red cell scans, when they are actively bleeding? It is clearly useless when they are not, but when they are actively bleeding, has that a role when you don't have access to capsule endoscopy?

Ian Gralnek: No, if you are going to go for another type of an imaging study, I would probably… you know, because tagged red cell studies are really not that great in terms of localization. If you are going to do something, if you really think they are bleeding, then I would really try to do something like a CT angio – so a CTA – which is much more sensitive and would be able to localize better. And if something is localized on CTA, then you can go directly to direct angiography and attempt to localize the bleeding site and potentially have interventional radiology treat that lesion. And again, that's going to depend where you are in the world and whether you even have that available to you, and whether you have an interventional radiologist available to you.

Paul Moayyedi: Great, thanks very much. These are very challenging patients for us as gastroenterologists. It's also true for the general internist, who often has to deal with these patients as well. So thanks for that. It's really helpful. So Pere, the question for you is when should you suspect acute-on-chronic liver failure in a patient with cirrhosis?

Professor Pere Gines: OK, first of all, good afternoon. It's a pleasure for me to be here this afternoon and to discuss the questions and I thank the organizers for inviting me to participate in this course. So, as you probably know, acute-on-chronic liver failure is a syndrome that has been recently defined [and] that is characterized by the presence of acute decompensation of cirrhosis together with the failure of one or more hepatic or extrahepatic organs. The organs that mainly have failure in acute-on-chronic liver failure are, of course, the liver, the coagulation [function], the circulatory function, the brain, and the respiratory function. So as you know, this syndrome is associated with very high short-term mortality; [it] is quite frequent and common in patients with cirrhosis and is the main cause of mortality. So the syndrome is defined, as I said, by the presence of acute decompensation of cirrhosis together with failure of these organs. And the failure of the liver is defined by the presence of a bilirubin concentration in the plasma greater than 12 mg/dL; coagulation failure [is] characterized by an INR higher than 2; circulatory failure [is defined] by the presence of hypertension with a need [to administer] suppressors to maintain an adequate circulatory function; and kidney failure [is] characterized by the presence of a serum creatinine concentration greater than 2 mg/dL or respiratory failure characterized by the presence of the administration of a significant amount of oxygen therapy, or perhaps the presence of ventilatory support. So, whenever a patient with cirrhosis meets these criteria – the presence of acute decompensation of cirrhosis plus the failure of one of these organs – then this defines acute-on-chronic liver failure. In practice, there are several definitions of acute-on-chronic liver failure: there is a definition in Europe that is based on the results of the so-called CANONIC study, [which] is mainly the definition that I just mentioned to you, but there is also a definition in North America by the NACSELD consortium, and there is also another definition in Asia by the Asian Pacific Association for the Study of the Liver. So, because the syndrome is quite new, there is still some controversy as to whether the criteria should be used for defining the syndrome. But in essence, it is characterized by acute decompensation of cirrhosis plus significant failure of one or two other organs.

Paul Moayyedi: Thanks very much, yes. Again, it's a dreaded problem in people with cirrhosis that general internists and hepatologists fear and it's good to understand what to look for as this is developing. So thanks for the question there. A very clear answer as to what we are talking about when we are talking about acute-on-chronic liver failure. So, there were questions on IBS as well. And one of them was… surely you have to do endoscopy because the definition requires that you exclude everything else. And what I would… Now, I've said that the Rome definition is great for research, but in clinical practice it's often easier just to look at a change in bowel habit and abdominal pain, with the abdominal pain being related to that change of bowel habit, either getting worse or better, when having your bowels open, and that's it. The Rome definition essentially says that, that we have much tighter definitions around timing, etc. But what Rome doesn't say is you must do a colonoscopy, because you don't have to. None of the guidelines, at least in those under the age of 50, without a family history of colon cancer, recommend colonoscopy. No matter where you are in the world, it is simply too expensive to recommend that – because the chances of you finding organic pathology are vanishingly small – and approach the risk that the colonoscopy poses to that person. So, if you've got a young woman with constipation, let's say a 20-year-old woman with constipation and abdominal pain, you do not do a colonoscopy; it is not a sensible approach – of course, assuming that other things in the history are not worrying. You will perforate her colon more often than you will find Crohn's disease. And that cannot be the right way to go and indeed, no guideline recommends it. So, it's all… why we don't have to do endoscopy is because if they have that symptom, you are over 99% sure they have IBS. That's better than most tests we use in medicine. So it is a symptom-based diagnosis and I cannot emphasize enough that you should make a positive diagnosis of IBS and not rely on an endoscopic test to be negative before you make the diagnosis. So, I hope that's clear. Obviously let me know on the chat box [if] I haven't answered clearly enough, please feel free to ask, but my basic message is if they have IBS symptoms, they are very likely to have IBS and you should proceed accordingly. They do not need extensive investigations. [If] they have diarrhea, [] antibodies and maybe a fecal calprotectin to ensure there is no inflammation that might indicate inflammatory bowel disease, if you have it available in your country. But otherwise, no other tests; just treat the patient appropriately. By the way, in the countries where you don't have fecal calprotectin and other things, the risk of IBD is even less. So, there isn't a big tragedy if you don't have those because virtually everyone in those countries actually has IBS [and not IBD], as long as they are young. OK, so we will move on to Irene again. And one of the other questions around gastroparesis was the use of itopride. Do you recommend that and what is the evidence for it?

Irene Sarosiek: Itopride, that's the drug which actually we studied on the research level many, many years ago. And the drug did not reach the level of FDA approval in the United States, but what happened, I think, [was] we gave the jump for other studies to be generated. And the data which came from phase II clinical trials showed that this drug helps with the symptoms of functional dyspepsia and in some studies even helped more with gastric emptying, but [] enthusiasm provided, based on the data from the study in regards to gastroparesis. So this drug is not approved in the United States for patients with gastroparesis and it's not used even on the level of an investigational approach only or in special, limited-access protocols. So that's something [that does not exist] in a clinic in the United States, but in Asia it's used. So this drug, because it is a dopamine type two receptor antagonist, is very similar to the properties of domperidone, which is not approved, again, here in the United States, because of the side effects and QT interval prolongation, which we know was very much in light of every investigator in Europe and around the world. So we have to watch what is happening, who can benefit, because if you have a drug – another one, for example, is prucalopride – which is popular in other countries also and helps with gastric emptying but [not] with the symptoms, then you just think [about] what is most important. The patients are very objective [in] the way they assess their being: they say I'm nauseated, I'm bloated, I'm vomiting; they don't know they have delayed gastric emptying. But on the other hand, gastric emptying is the only objective test which can tell you if you are delayed with it, so you can make the diagnosis. So that's something that goes in a circle and is very difficult to [nail] down. But I have to tell you, there are actually agents which are being studied right now and, even in the United States, a few pharmaceutical companies are conducting studies. These are phase II and III of [the trials] and I hope that we will have some of them available on our market soon. They seem to be very promising and maybe they will be clear with their cardiovascular side effects and maybe we will have global approval of those new-generation dopamine receptor antagonists, besides reglan – which is fully approved – and domperidone – which is approved under certain circumstances only. Therefore, we still have the same arena for going after the drugs, but we don't have full spectrum. Many of the drugs we studied in the past – we failed them because of the functional nature of gastroparesis. So itopride is not well recognized [but] there is [also the drug] TAK-906 and another one for another company also, NG-101; maybe they will get to our clinics very soon.

Paul Moayyedi: Yes, actually you raised the point of the cardiac dangers of these drugs, because they nearly all prolong the QT interval. Prucalopride is probably one that does not, but all the others do, and prucalopride is primarily used for constipation.

Irene Sarosiek: Well, it's good you mention this because I know we want to study it in gastroparetic patients, we have done prucalopride before but not to the full extent. And I think there were very good studies coming from Europe or in Canada. They've done a study in Canada [where] they very nicely improved symptoms with those patients, in accelerated gastric emptying, but the symptoms were shown to be improved in a study then in Belgium, so there is a mixed message right now. We hope to have something more done – maybe on the level of our consortium – and to clarify the dose: 4 mg, 2 mg. So that's the future.

Paul Moayyedi: Right. OK. Thanks very much. So we'll mix it up, Pere next. A question which I think I know the answer already, but we want to help the listeners here. They're asking when patients with acute-on-chronic liver failure should be on the transplantation list.

Pere Gines: OK. Well, this is a very important question and also very important from a clinical perspective. My opinion is that all patients with acute-on-chronic liver failure should be taken into consideration and evaluated for transplantation. This is because the short-term mortality of acute-on-chronic liver failure is very high. You know, the majority of the patients have a mortality at 3 months that could be around 40% or 50%. So this means that the mortality in the short-term is very high. With transplantation, this mortality decreases to 10% or 15%. So we can increase survival markedly by transplanting those patients. But the main challenge – there are two main challenges in the transplantation of these patients – the first challenge is to keep them alive until transplantation can be performed. For this, there are a few things that are very important. One is to identify the precipitating factor of the acute-on-chronic liver failure, which in the majority of cases – not in all of them, but in a vast majority of cases – is a bacterial infection. So to identify bacterial infections early and to treat them early in these patients, and also to give the organ support that is required [to keep] the patient alive. And to do all of this, it is very important that the patients are in very specialized centers with a liver transplant program, because one of the main problems is that these patients, if they are kept in small hospitals without a liver transplant program, usually when they are referred to the large hospitals, they are referred too late and they have refractory acute-on-chronic liver failure and they have contraindications for transplantation. So, early referral of these patients to transplant centers is extremely important. And the second issue, in addition to keeping the patients alive and referring them to large, specialized transplant centers, is to do a very rapid evaluation of these patients because these patients are usually in a very poor condition, so they need to be evaluated for transplantation very rapidly. So we need to perform fast and effective evaluation for transplantation to identify those potential problems or comorbidities that could contraindicate the transplantation. And again, this also should be performed in specialized centers. So the main message is that a relatively young patient – and “young” means below 70 at least, you know – that develops acute-on-chronic liver failure should be referred to a large, specialized center with a liver transplant program if we want to improve the survival of this patient, because other than transplantation and treating complications, there is no effective therapy that has been demonstrated to improve survival in these patients. So transplantation is the key for success when treating patients with acute-on-chronic liver failure.

Paul Moayyedi: That's very clear. I mean, my thought is the key thing you need to determine as a general internist, or indeed a general gastroenterologist, is those that are clearly not candidates for transplantation. There is no point sending them to a transplantation center if that's not what they are going to have. So, first, that means early dialogue with the transplant center, but also knowing the clear contraindications. In Canada, anyway, if they are drinking alcohol or have only stopped recently, that's a clear contraindication outside the clinical trial. Is that fair to say, Pere, and just help the transplantation center if you know there are a certain body of patients that don't need transplantation input?

Pere Gines: Yes. Well, this point is very important. So it is important to have a very easy way to contact the transplant centers – either by video conference, you know, teleconferences, whatever – so that every patient can be discussed at very early stages. And the main contraindications for transplantation are age: usually over 70, you know, the majority of centers do not transplant these patients over 70 years old. Then, active alcohol consumption – you know, there has been a lot of debate of whether patients with alcoholic hepatitis should get a transplant or not; there are pros and cons about this decision. And in fact, the current concept is that only in specific centers and with very specific patients that have been evaluated, you know, with respect to the social issues, personal alcohol issues, only a very small proportion of these patients can get transplanted. So, in general, active alcohol consumption is a contraindication for transplantation in the majority of centers. And also, the presence of important comorbidities, for example, the presence of a neoplasia that has been treated recently, a patient [with] important cardiac failure [or] respiratory failure that is not related to liver disease. So all these are absolute contraindications for liver transplantations. But other than that all, other conditions should be discussed with the transplant team and at very early stages. I think it's very important.

Paul Moayyedi: Right, thanks very much. It's very good advice. So, Ian, the next question was regarding… what do you do with a patient with overt GI bleeding, when you've done all the colonoscopies and endoscopies, and the video capsule endoscopy is negative, but they are still bleeding? What do you do?

Ian Gralnek: So, if they are really still bleeding, first of all… I mean, bleeding can start and stop. You know, if the capsule endoscopy is truly negative but they are still having ongoing melena or hematochezia, then I think you would really have to go straight to something like a CT angiography to try and see where they are still actively bleeding from. If you take a patient who has had sort of intermittent, obscure-overt [gastrointestinal bleeding], you've done an endoscopic work-up and you do the capsule and nothing obvious has been found at that capsule endoscopy, then you are sort of going back to the algorithm of “OK, then what about doing a CTE or an MRE to further evaluate the small bowel at that point?” You can consider even potentially – depending on the history of the patient – in occult bleeding, you actually could potentially step back and follow them symptomatically and see what happens. But if they really have ongoing overt bleeding, you really do need to be more aggressive in trying to identify the site of bleeding. So you get more to the radiologic testing … if they are having symptoms that could be consistent with Meckel, you could do a Meckel scan and you can even repeat a video capsule endoscopy, if [you] needed to. There is some data to show that a second capsule may be able to pick up lesions that might have been missed, especially some types of some mucosal lesions, something like GI stromal tumors that may have ulcerated but were missed at the time of the initial video capsule endoscopy. Can I actually ask a question myself of Doctor Sarosiek?

Paul Moayyedi: Yes, surely.

Ian Gralnek: I have a question. What about endoscopic therapies – being an endoscopist –what about endoscopic therapies? What's your experience with endoscopic therapies for gastroparesis? And specifically things such as botulinum toxin injection, the pylorus G-POEM or gastric peroral endoscopic myotomy, even ultrasound: EUS-guided gastrojejunostomy with lumen-apposing stents, things like these. These are sort of cutting-edge endoscopic treatments and, of course, this would be in patients who are completely medically refractive to any type of therapy and have ongoing symptoms of gastroparesis. Is there anything like this going on in Texas or near you in the US?

Irene Sarosiek: In the US – absolutely. This is a very hot potato; everybody now is focusing on pylorus, because based on our studies of the tissue which we took samples of during the surgeries in patients who qualified for the implantation of a gastric neurostimulation system… and that's something we are doing here and I work with [] since 1998 on this therapy. So we have a chance to take a sample from the body of the stomach and then, at some point, we added another procedure to our implantation of the device and the whole system; we added pyloroplasty, and that's how it started to go everything around the pylorus area, because we showed that changes in the number of [interstitial] cells of Cajal (ICC) in the antrum of the body was much higher than the number of those cells in the pylorus. That's why we started to focus on the area in the stomach, which until that time was almost unavailable to us; that's how many procedures are endoscopic approaches. They took place and they went just with the flame of a match, so many things right now are happening and I am very pleased because we added Heineke–Mikulicz pyloroplasty to our menu of surgeries and we have seen very impressive results. Of course, not every patient will qualify to have surgery done, even though it's laparoscopic, even though it's done with a robot, they usually… this is the last extreme case: when patients fail all available therapies, they can go into this arena. So what to do? Right now, endoscopically, you have G-POEM procedures, we don't do [them] here in our hospital, but it's very popular. There are very good results coming from side centers which are doing this. You have to do [] very often to test and see if the changing of the tension and distension of the pylorus will be helped [by] the procedure, so you can see before and after. This is already [done] in investigational approaches. You also mentioned a very old method [that] still available: injection of botulin toxin. Botox injections, which are done in [] area of the pylorus… 200 units of this toxin in many patients paralyzes the pylorus, which again will make opening of the door much bigger for the food to go down. So the gastric emptying will be improved, which we now should push or pull improvement of the symptoms because many things in gastroparesis are related to the stasis of the food there. And that's what is done. Botox injections, this was like a few years ago, everybody was doing it very [often], so now we are more, maybe skeptical, waiting for further results to be shown. We have done [the injections in] patients here in El Paso also. But there is a tachyphylaxis, like with any Botox in any area: [over] time, the medication doesn't work, so you have to think about [more] injections, which with a second attempt will be less effective. So this is now the first choice, if you have better approaches now, an endoscopic one. There are centers which are very good and they are doing this and I think the major focus of gastroparesis is going to focus again on the pylorus, nothing else, maybe additional. But that's where we are heading and that's what we are going to do. Even biopsies then, during the endoscopies, now go after full thickness of the wall. And we can dissect and do the sub-channeling and take a biopsy there, we have an endoscopist here. So it's very interesting and this is a field which is growing like a mushroom and I hope a year from now, we will talk only about this. Maybe we won't need many other things in surgeries in those patients. So, a very good question. Thank you.

Paul Moayyedi: Yes. Can I add to that? Just a note of caution, as an evidence-based guy, and this the McMaster forum for this. My concern with these [] and exciting approaches is they're often reported in case series, you know, “I did 20 patients like this and 15 got better.” Unfortunately, the reason we have evidence-based medicine is we know that can be misleading and you really need randomized trials to know whether something is effective or not. And that is one of the challenges of these newer approaches, that they are often not evaluated in this way. And so, it's often hard to know what you are really achieving. Would you like to comment on that, Irene – or Ian, as you asked the endoscopic question? Because this has to do with those.

Ian Gralnek: I will jump in quick. So my answer is [that] I agree with you, Paul, completely. We do now, in terms of doing esophageal POEM for achalasia, we do have randomized controlled data, right? And that's been published. And it's as good as, if not better than surgical Heller myotomy for achalasia. Now, I agree with you. We need to wait, we are going to need randomized trials looking at, like a G-POEM and I think we will eventually get there. But you are right, I mean, these are either retrospective or prospective case series done by 1 or 2 highly skilled individuals with highly selected populations. So you need to take the results with a grain of salt and I agree with what you're saying. I think we are going eventually see those RCTs.

Irene Sarosiek: Absolutely. And I will tell you, we were challenged by the whole entire GI in the whole entire world regarding pyloroplasty and stimulation – like, what is better? Maybe we don't have to stimulate, we could do pyloroplasty, even a surgical one, not through the endoscopic approach. So we have to design the study, when we have done 2 of them. But I will tell you, to do a randomized clinical trial, when you have 2 surgical approaches provided at the same time [is] very hard because… how do you make a placebo? From the ethical point of view, you know, to do a study where you have a procedure done and tell the patients “oh, you were randomized to not have procedure done,” you know? Or how do you tell them? So there are many things which are behind randomized clinical trials which are very challenging for everyone. For us, we didn't turn on the device. We kept the device off so the patients were only relying on pyloroplasty, to see the results of our therapies when they were combined together. And then at the end, we turned on the device so everybody got [the full] spectrum of the goodness of surgery in those very debilitating, very sick conditions – in gastroparesis. That's the future. We're not there yet with everything; that's absolutely right. RCTs are necessary.

Paul Moayyedi: So yes, exciting technology: it's important to be positive and enthusiastic about it, but also to have criticism about how good the results really are, because every randomized… while it's true – although Ian's example is perhaps one of the exceptions – usually what is true is that whatever you think in the case series [or] randomized trial, even if it shows it works, it doesn't work as well as you are claiming it does in the case series. That's almost universally true. So it is important to do those, once you have perfected the techniques that you are using. But anyway, we just… we're sticking on gastroparesis because it's clearly a very important topic for the group that are listening here. The next question is: “What is the worldwide accessibility to the [] capsule? And is there any room to work outside of motility.”

Irene Sarosiek: That's, we are very far. I just included this because we are actually as a center involved in the first pilot studies – very far from the randomized trials, if we have anything done in this fashion. But we are designing, we are going after some grants. It's not available anywhere in the whole entire world. It's just the first baby step in gastroenterology, but it carries good value if it is proven to the point because now we have done only studies in healthy subjects. We are going to go after gastroparetics and [] and the whole positioning of the capsule will be proven to show exactly the transit times through all regions and then it will be wonderful to have this available. The capsule, which is approved in the United States for utilization for diagnosis of gastroparesis and constipation, actually is the SmartPill. That's another capsule which is very old. We studied it in 2007, when we started investigations of this wireless motility capsule and this is the one which is available for testing patients, even in El Paso, in the corner of one of the clinics here in our institution. Again, it just shows the time duration when the capsule is in the stomach, the change in pH – which is [from] one of the sensors … in the capsule – it leaves the stomach, goes to the duodenum, and then, again, when it's in the small intestine and you have all assessment of the whole gut transit time done by one capsule which is not invasive, [does not require] isotopes, and patients go home and live [their] normal life and the test is going on for 5 days until the batteries die – they actually die in the receiver. So, capsules are very popular. I [showed] this small slide only just to tease everyone [with] where we are heading with technology. I love gadgets and that's why I am you know, just probably testing them on the patients and just very enthusiastic about it. But that's where we are heading. It's not available anywhere, just in the investigational approach in the United States: we probably only have 2 centers right now which are doing studies. Sorry, not yet.

Paul Moayyedi: The message is [to] stick to your gastric emptying studies: it's locally available; the capsule is for the future. So I just… we've only got a few minutes and I've got to answer a question as well. But just over to Pere, quickly. I think we've answered this, but it's still in the inbox: Roman Jaeschke has asked, “which patients would you not transplant?” So we talked already about [those] with malignancy and with alcohol. Any others that you would highlight?

Pere Gines: Yes. Well, I think that we need more information for the transplantation of very sick patients. These are patients who have failure of 4 or 5 organs. So those patients who have very advanced acute-on-chronic liver failure, we need more information with respect to the success, and also, you know, the possible mortality after transplantation. So I would emphasize that very advanced patients probably are not very good for transplant.

Paul Moayyedi: Alright. But the important message is to talk to the transplantation center and then you can come to that determination.

Pere Gines: Yes.

Paul Moayyedi: Clearly as an 90-year-old alcoholic, you are not going to even call the transplant center: you know the answer. But generally it's important to collaborate with the transplantation center in reaching an opinion. So, the final question relates to IBS again and to what I said before. What about those with severe symptoms? Surely they need a gastroenterologist and that's absolutely true. Primary care and general internal medicine is where you would manage these patients, initially. But the ones with more severe problems – absolutely, you would send [them] to a gastroenterologist. Now, it's not that we are magical or have different treatments than you have, but we have more experience in IBS, at least many of us do. And we often can spend more time than the primary doctor can in initial visit. And of course there is the ivory tower effect. All of those things go to reassure the patient [and] can lead to some patients going into remission. So it's clearly true you should do that for select patients. And the same is true for us. In those that are really severe, often cognitive behavioral therapy with a psychiatrist may be helpful, because they can spend even more time with them than we can and explore the psychological issues with more expertise. So it is a hierarchy which is focused on their problem and their symptoms, but it's not that we have any more magical treatments and it's not that we have access to colonoscopy, that is, the reason for the referral. And the final question, yes, someone said we consider you magical. And the answer is [that] we are not, of course, but there is [00:51:52 – problem with the connection] in the consultation, as I said in the lecture. We seem to forget that with all the wonderful tests we've had – a lot of which have been mentioned in these talks – [which] are important and they do help our patients, but we must not lose what we already have, which is the healing power of our words and actions and that we show we really care for the patient, there is a patient in front of us and trying to help the symptoms in itself can be very therapeutic. And…

Irene Sarosiek: I can only add one sentence to this. The same story absolutely [applies] to the gastroparetic arena as well. Because it's a functional problem, we have people who come to us at the end of many years of suffering and then they have to come to the motility center, they have to be evaluated. More options are there and more sophisticated tests are done. So that's why, you know… just don't keep those patients if you don't know what to do with them; send [them] to somebody next door and maybe they will be more helpful. Please.

Paul Moayyedi: Yes, but often it's not the magical things that we have. It is the authority that is given upon us as expertise in that disease. And also the time we can spend with people that often a busy internist, for example, may not be able to do on this particular problem.

Irene aerosiek: That's right.

Paul Moayyedi: So I don't want to say we don't do anything, there are key people who are clearly helped by that specialist knowledge, but there is a general effect as well which we shouldn't neglect. Now, there's another question on the differences between the American and the Canadian guidelines. That's an interesting one. It's interesting because I was the methodologist on both and chaired the Canadian guidelines. We did it at the same time and both were aware that I was doing this for both. And yet they came to different conclusions when presented with the same evidence. And that is the nature of… Even when they are using [] is the nature of the panel that you select and that country it's done in. So, there was a question around wheat bran versus insoluble. I think both [guidelines] said that soluble is the way to go and wheat bran is insoluble. So generally, for IBS you should be using psyllium. There are other soluble brans but psyllium is the one that's widely available in most countries in the world. So, that I'm not sure, I mean, I wrote both so I think I'm right in saying that wheat bran was not recommended in either, but psyllium was recommended in both. But what was different was that the American guideline recommended rifaximin, a non-absorbable antibiotic which has been shown to be effective in IBS of diarrhea or mixed type, whereas the Canadian guidelines did not recommend that. And part of the reason relates to the different cost structures of the system. I think even the US group felt this was an expensive way to go for a very limited efficacy. But it still works, so they were happy to endorse it. The Canadian system is a little bit more cost-constrained, so there was concern around, you know, is this really worth it? But the other important factor was that the Canadian group had primary care doctors in it, as well as a patient. And the primary care doctors were very concerned about giving more antibiotics to that population. They'd been taught not to do that, so now we tell them it's OK? They didn't like that. And the patient, too, said that a patient's view of IBS is that it's not an infectious disease. And they take antibiotics for infections. So the moment you start rolling out an antibiotic, even if you wave your hands and say “dysbiosis,” they are going to think “you don't understand my disease; it isn't an infection.” And generally, things do not work in general care – not in randomized trials but in the clinical practice – if you just hand them an antibiotic and expect them to get better. If it doesn't fit with that paradigm of what they think their disease is, they are unlikely to respond well to it. So those are the reasons that the Canadian guidelines did not recommend rifaximin. Now, it isn't to say that the next guideline won't either. It may say “yes,” simply because our understanding of the disease has changed, maybe the costs have reduced, other things may change. But it is interesting that 2 groups presented with the same evidence can come to different conclusions and part of that relates to what groups are in guidelines. And I think these are lessons for us that for things like IBS that affect – let's face it – primary care a lot more than GPs, that we should be having a multidisciplinary panel and not just a group of gastroenterologists who decide on these things. So, that was my answer to the question on the difference between the US and Canadian guidelines. And by the way, I'm not saying any of them are right or wrong. I would say that both are right for the country they are in. Primarily in the US, you will go to a gastroenterologist with your IBS, but in Canada primarily you will go to a GP. And the outlook of those clinicians is different and I think it's appropriate that sometimes we manage these things differently; I think that's fair. So, yes. Another question was on the use of diary. I think if it helps the patient understand that you are taking it seriously, absolutely. They're often used to see if we can find food triggers. I think Irene may agree with this with gastroparesis as well, that the problem is that strawberries, for example – just to throw something out there that may not apply to gastroparesis, by the way – but strawberries may make the symptoms worse one day and they're fine the next. And so really, to highlight a food that really precipitates symptoms is often quite difficult, but I'm fine with patients taking [their diaries] to me and I will look at them because I think it lets them know that you're taking their disease seriously. So, there are… So we are right on time now. I was told to go 5 minutes over and we are 2 minutes before that. So any last words from any of you? It's been a fantastic session. I really enjoyed all your answers and I've learned a lot. Hopefully the group has learned a lot as well.

Ian Gralnek: Thank you for everyone. Thank you for moderating, Paul.

Irene Sarosiek: Yes, you have done a very good job and I have only a question to ask you, but probably it's not crucial. I was wondering: Do you do the SIBO [small intestinal bacterial overgrowth] test on patients who are diagnosed or come with symptoms which can, you know, just be diagnosed as IBS? Obviously, pain is a problem there; we know it's very psychologically driven in some of the patients. We are still in diapers with this condition, I think this is very difficult. But just in that case, do you do SIBO tests on those patients? Because, obviously, they get antibiotics, mainly.

Paul Moayyedi: So we don't recommend it in the guideline and I only do it for very select patients. So there are the occasional patients where that is appropriate, but generally we do not do it with just the IBS symptoms.

Irene Sarosiek: And sorry, I didn't say what SIBO means, so just for those who don't know, this is small intestinal bacterial overgrowth. That's a condition which causes pain in the lower-right quadrant and that's why we sometimes look for the reason [behind] those problems by doing the SIBO test. Thank you.

Paul Moayyedi: OK, well, thanks very much everyone. And enjoy the next session. Thank you. Bye now.

Co-financed by the Polish Ministry of Education and Science within the program „Doskonała Nauka”
(„Excellent Science”)

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