So we're going to move now to the session two, which is live endoscopy on the endoscopic treatment of GERD. I want to introduce Reina, our co-moderator. Thank you, Reina, for being with us. And also I want to introduce Venkat from Hopkins. He's one of my colleagues at Hopkins and Linda Zhang, one of our advanced fellows at Hopkins. They will be the coordinators for the live endoscopy to coordinate between centers and also on the back channel to make sure this flows seamlessly. We're going to switch to you, Venkat, if you want to connect us with Amit. Thanks, Dr. Kashyap. So we are going to India for live endoscopy. First, we will be going to Bildota Institute of Digestive Sciences. Dr. Amit Mehdio will demonstrate the GERDEX device. Dr. Mehdio, you're live on. Yeah. Hi there. Can all of you hear me well? Yes. Yeah. So first of all, I would like to congratulate and thank Professor Moin Kashyap and Professor Pratik Sharma, course directors of this wonderful course, for asking us to demonstrate to you this new technique of endoscopic full thickness placation for patients of GERD. So as all of us know that these modalities of endoscopic treatment of PPI-dependent GERD are just on the horizon over the last decade or so. And I'm going to demonstrate to you one such new technique which presently is being practiced in Europe and some parts of Asia. Of course, we have been doing it in India since a few years now. And this is called as GERDEX procedure, which is actually an endoscopic full thickness placation. This is mainly practiced for those patients who are PPI-dependent GERD. And first, before I start the procedure, I'm going to show you how this device looks. So this is how the device looks. So this is how the handle of the device and this is the distal end of the device. You can see that there are two arms at the end of this device and in the middle there is a channel. So what we can do here is basically these two arms can be opened and closed by moving this lever. So we can do move this lever here and then we can close these arms by turning this handle. And then we can also open it by moving the lever on this side. Then if you see here, this device has got this wheel. So by turning this wheel after this device is passed inside the stomach, this device can be completely turned in a U-shape so that we can bring the two arms towards the esophagogastric junction. Now all these procedures of endoscopic treatment of PPI-dependent GERD are basically are for remodeling the esophagogastric junction. And the ideal candidates for doing an endoscopic full thickness placation are those patients who have got symptoms but on endoscopic appearance they have got Hill's grade 1 or 2 or maximum Hill's grade 3 type of a lax hiatus. And how do we actually suture this device is by using this suturing system. You can see here, these are the two pledges which are fixed on the two arms at the end of this device. And over here, if you were to see, this is the suture and you can see this titanium anchors to which is attached this PET grade suture material, PET, which is complete 100% polyester, which is silicon coated. And over here, you can see a PTFE, that is Teflon pledget. So a Teflon pledget on this side, and this is the receiving system over here. On the receiving system where the anchors will go inside and anchors will get fixed to this pledget. So therefore, basically, these two pledgets will go through and through the tissue. And that's how we are going to do a full thickness suturing. Now, if you were to see, now I'm going to open the two arms. Now I've opened the two arms. And after opening the arms, if you see in the middle, in the middle, you have, you see this tissue retractor. Now this tissue retractor has got a covering sheet. And if you pull the covering sheet, and if you focus on the tissue retractor, it is like a screw type of a helix. So by rotating this screw type of helix, we can actually go inside the stomach wall, the area of the OG junction in a U-shaped fashion, and then pull the tissue in between. So then I pull this retractor inside. And after I pull the retractor inside, I'm going to close. So I'm going to show you how I actually do the suturing. So now I'm going to show it, demonstrate to you on this sponge here. So I'm going to hold the sponge in the middle. Then I'm going to bring this to the closing position. And then I'm going to slowly close it. And once I'm sure that it is properly in place, then I move this lever onto the fire position. And then I fire, fire the pledges through and through this sponge. And that is exactly what is going to happen through and through the stomach wall. Now, once I fired it, then again, I'm going to open this. And once I open it, you keep on holding the sponge there. And by moving this device, you can actually disconnect the wall, pull it. And you can see here how this gets actually placated through and through. Now here, of course, you have to use a little bit of force because it is a sponge, so it got fixed inside that. But inside the stomach, this releases quite easily. Now, how do we get a vision while doing this procedure? So through this channel, we pass an ultrathin endoscope. So this is how we pass the ultrathin endoscope. Once this device has been passed inside the stomach, and you see here, there's a separate channel for this endoscope to come out. So once I pass the ultrathin scope, you can see how the endoscope comes out. And then you need another assistant to maneuver the endoscope. So this is how the endoscope was in the stomach. Now I'm going to turn the device in a U-shape, and then I also turn the endoscope in a U-shape, and then pull the endoscope back so that then I can start seeing exactly what we are trying to do. So this is how we actually perform the procedure. So now we have a patient here who is a 30-year-old boy who has got PPI-dependent GERD, and his main symptoms have been heartburn, and the second symptom is, of course, global sensation. And his high-resolution manometry is showing a normal esophageal peristalsis and an IRP of 9.3. His pH metric we did, and he's showing 157 reflux episodes. And if you see the acid reflux composite score, that is the DeVistar score, DeVistar score is 180.8. His symptom, that is GERDQ score, is 15. So he's an ideal candidate because on endoscopy, we found that he has got Hill's grade 2. So I'm going to demonstrate the procedure now, and I'm going to go now towards the patient where I've already passed the scope inside the stomach, and I'm going to give you the endoscopy picture. And if you see the endoscopy picture over here, you can see that this is a Hill's grade 2 type of a lax hiatus. You can see that. So it doesn't look like a large hiatus hernia, but this patient is PPI dependent and all the parameters and all the objective methods which we used to assess his acid reflux, we found that he's an ideal candidate that he requires an endoscopic full thickness placation. Now, this is a device which is a little cumbersome to use because it is thick. It is 18 mm. So therefore to pass it, we have to pass it over a guide wire. So I'm going to use this special guide wire which looks like a savory guide wire, and this guide wire has got flexible tips on both the sides. So what I'm going to do is pass this guide wire right inside the pylorus and then start inflating air inside the stomach, and I'm going to pull the endoscope out. So I'm going to push the guide wire over here, and as he's pushing the wire, you can see how the OG junction is appearing open when I'm pulling the scope backwards. So I'm leaving the guide wire in and pulling the scope out, and after I've done that, then this device is railroaded on the guide wire. Amit, do you have to dilate the upper SFGL sphincter? No, no, you don't need to dilate because this is not a very thick device and it can easily pass through the cricofirings almost as easy as you can pass in an endoscope. You see how what we are doing now? We are now putting the guide wire through this channel, and then the guide wire will now come out through this channel over here, and now we start pulling the wire on this side, and as we pull the wire on this side, I'm going to slowly pass this device. Can you focus the camera down a little bit? And now, can you see this, how I'm passing this? And you can actually move it. Give the external camera a big picture, please. Yes, see how this device looks good. Amit, so the question is, is this, I'm seeing the patient's not intubated and stuff, so this is under propofol? Patient is intubated, patient is intubated. Okay. So I have passed this device until it comes to 55 centimeters. There are markings on this device, almost like an endoscope, and the next thing to do now is to insufflate the stomach. So I'm going to use this manometry cuff here, like a sphygmomanometer cuff, and then we will inflate air inside the stomach to keep the stomach inflated. Now once the stomach is inflated, now I'm going to pass the endoscope inside. You can see the endoscopy picture, which is inside the channel of this device, and I'm going to pass this scope inside the stomach. Now you see here that the scope has gone in the stomach. You can see that. Now I'm going to push the device in and gently turn the device in a U-shape, completely U-shape, so that it comes towards the OG junction. So Amit, these are full thickness plications, huh? Yes, it is a full thickness plication. So the next step to do is to open the device. I'm going to open the two arms of the device. Now there are various methods of full thickness plication or remodeling of the OG junction. You can either do it on the greater curvature over here, over here, or you can do it on the greater curvature. Over here, over here, but I usually prefer to do it on the lesser curvature. So the principle is almost as if you are doing an anti-reflux mucosal resection or a ARMA procedure, where you have secretarized the lesser curvature part of the LES so that the greater curvature gets pulled up like a sling. So what I'm going to do now is I'm going to rotate this device and bring it towards the lesser curvature. So see what I'm doing now? I'm rotating it and as I'm rotating it, even Sehzad is also rotating the scope. So I'm going to take the device a little bit away. Sehzad is basically an endoscopist. And position my place properly, give a little insufflation. Now, Amit, have you seen any differences in results based on the lesser curve versus the greater curve plications? Yeah, I have found lesser curve plications to be better. I need a little bit better vision with the scope and insufflation of air a little bit. Can you plicate both or it causes dysphagia? No, we can plicate both, but I usually prefer to plicate tabular ferroscope. Now, what I'm going to do now, I'm going to pass this helix a little bit over here and now rotate it. And I'm going to pull the tissue inside, fix it. Now bring the device a little bit nearer. Air is not insufflating. And now, once I come to a reasonably good position, I'm going to bring it to the closed position, gently close it. Okay, push it back. Wait, I'm going to release it a bit. No, release it a bit. Yeah, I'm going to take it a little bit on this side. So, Amit, as you did that nicely, as you brought it back in, is that because you thought you had too much tissue? No, I thought I was not in the right position. I need to go a little bit on that side. So, I need to turn the scope also on that side. Yeah, this is a better position. A little bit near. This is a better position. See, this is the right area which I want to pull inside. So, as close to the G-junction. Yeah, but we should not enter the esophagus. Yeah. We should go in the stomach. So, see what I've done now? Now, I pulled it, fixed it. Now, I'm going to rotate it a bit, bring it a little near. Over here. Amit, is this the newest version of this device? This is the latest version. Now, see what I'm doing. I'm slowly closing the device and turning it so that it's like a fundoplication. So, again, open it. The helix has come out. So, it doesn't matter. So, we'll go in again. Are you able to do this in patients with small hiatal hernia or have you done any of these with hernia? So, Reina, while Amit's doing this, can I ask you a question about Reina in your practice also? How do you decide candidates for antireflux procedures in general? Yeah, I think it's really important. You're really trying to get that right phenotype for who should go to surgery versus endoscopic antireflux intervention. Definitely someone who's had confirmed GERD, of course, elevated acid exposure. Generally, that gastroesophageal flap valve, he'll grade one or two, very small hiatal hernia. We might consider more for the endoscopic interventions. Now, it's a little better. If there's any component of reflux, hypersensitivity or functional heartburn, we may really try to optimize their medical management and lifestyle before considering any other options. Gotcha. Okay, good. Because we'll be seeing other examples as well of different procedures which are conducted and several of them, including this one, has been tested in sham control trials. So, there was a publication in Gut last year on comparing this procedure that Amit is demonstrating for us with a sham procedure and showed a significant improvement in health-related quality of life issues. So, I think there's good data now from RCTs doing that. Amit, back to you. Amit, so it sounds like you've been able to grab it at the right place. I've now fired the staple and now I'm going to open the helix, release the tissue and I'm going to open the staple. Amit, how do you decide how many placations do you do just based on visualization? Normally, one placation is sufficient. If you do it at the right place. So, the other question, Amit, is, you know, with TIF, we pull the esophagus down. So, if there is a small hernia, we reduce it. Here, this phenomenon is absent with this device, right? So, there have been studies looking at, you know, more than one, you know, pledget as well going in there. So, you could put, again, as Amit was showing, he goes more on the lesser curve. If you put it on the greater curve, you could put up to two or three placations in there. So, Amit, the question was, with TIF, we pull the esophagus down. So, if there's a small hernia, we can reduce it. With this device, this phenomenon doesn't happen, right? That is not required, but what we can do is, we don't need to pull the esophagus down, but we can take a placation at the same time we can rotate it. It almost looks like a fundoplacation. You can see this pledget here. Now, in this particular case, if required, we can apply one more placation. Dr. Medeo, we will switch rooms in two minutes, then we will come back to you after. So, Amit will be moving out in two minutes. If there's anything you want to show us more at the end, we're happy to switch back to you. Otherwise, thank you very much. Any final words? How the placation looks. Yeah. Yeah, we can see that very clearly, Amit. So, you know, very nicely done. And, you know, the way you rotated the scope and showed us how to get closer to the lesser curve, I think, for all budding endoscopists, I think a very nice technique, I mean, with or without this device is showing the critical way of how you get close to the G-junction in a retroflex position. So, thank you very much, Amit. Yeah, thank you so much. Amit, any final words before we move? Also, this is one of the most user-friendly devices. So, and there are various methods of using, and I usually prefer a lesser curvature single staple EFTP procedure. But you can always do a greater curvature. You can apply one or two sutures and sort of enhance the angle of his or remodel the gastroesophageal junction. So, it's a very good procedure. Yeah, it looks easy enough to use, actually. But this was a beautiful demonstration, Amit. Thank you very much. Hopefully, you can stay with us for the Q&A session, if possible. Yes. Back to you, Venkat. Thank you.

GERDEX procedure

endoscopic treatment

GERD

esophagogastric junction

PPI-dependent GERD

suture