that based on the data that Dr. Sullivan presented earlier in the prior session, showing that about 70 to 100% of the patients, balloon patients, were able to maintain their weight loss at six months after balloon removal. So based on that data, when would you recommend adding pharmacotherapy to patients with intragastric balloon? So that is an excellent question because there have been some studies which say that there is weight regain, and there's some studies which appear to be saying that there is sustained weight loss at six months at removal. So in these cases, it might be still reasonable to start at the time that the balloon is removed. That way, you wouldn't have as much of an overlap. And if you're going to be using agents, that would cause some of the same side effects like increasing nausea and GI intolerance. It might be reasonable to do it at the time of removal of the device, so that way you can have sustained weight loss. Now, the studies that have been that haven't really done it at that time point, there are no studies, at least published studies, which have done it at the time point of removal of the balloon, but I think that's a reasonable place to start or another place would be when you start experiencing weight regain because when we're using anti-obesity medications, we wait for weight stability in a lot of cases in our practice, but if there is a chance that the patients start seeing an increase in appetite and weight regain, that's a good place to start it too. So it could be either one of the two that you could do it, although obviously the study from New York and other academic centers that were involved, the four academic centers showed that they were able to start it right at the time of implantation of the device. Thank you. All right, so for Dr. Schumann, so you mentioned in your talk that people have been pushing to use pigtails earlier and earlier now. So in your practice, what was the earliest leak you have treated with a pigtail or two pigtails? And would you consider using pigtails as a bridge to help patients come out from an IR drain sooner? Yeah, that's a great question. And I apologize, my system has some firewall against the camera for some reason, but that's a great question. So I had heard at a variety of different conferences just prior to COVID that some of the surgeons who had presented had said that they had been exploring the use of pigtails a little bit earlier for their own leaks. So I have similarly adjusted my practice. The thing that is a little bit different is that because there's no formed wall in the perigastric cavity at that point, I don't over-inject contrast and I don't go out and actually debride the area at all. What I end up doing is simply, basically just looking under fluoroscopy, trying to get a sense of the size of the cavity and then placing small plastic pigtail stents for that purpose alone. I do think that it has many options in terms of trying to get that IR guided drain out a little bit earlier, but we haven't actually done any discrete studies as to whether or not early or late drainage is more effective. For me alone, it's more just a change in my practice on how I actually place those pigtail stents. And I also think that typically with early leaks, those that already have drainage through the abdominal wall and so you can either primarily close them or sort of cover them with these covered metal stents, I find that those are the ones that can sometimes be the most challenging to treat because there's edema in the area and the covered metal stents that you're tempted to place commonly migrate. Even if you suture them, I think the data supports migration about 15% of the time. And patients tend to be somewhat uncomfortable with those. And so what I found is that a couple little plastic pigtail stents, as long as you're not over-injecting the cavity or risking using your wire and having that sort of perforate through the back wall of the cavity, as long as you can do it sort of safely, I think it's a reasonable option and patients seem to be a little bit less symptomatic. Yeah, thank you very much. That's very similar to our experience here as well, where we start to do it a little earlier and earlier. Sometimes it's not completely, completely formed yet, but as long as we have that safe technique, it's okay to proceed. All right, Dr. Millard, thank you for a wonderful talk. So we love hearing a great collaboration between obesity medicine experts and bariatric endoscopy experts. So at University of Colorado, so between you and your team and Dr. Sullivan, is there a certain referral pathway for patients with obesity who come into the center? How do you triage whether they're gonna see obesity medicine experts first or bariatric endoscopy experts first? And also for patients with weight regain, do you generally start them with pharmacotherapy or do they go directly to Dr. Sullivan for bariatric endoscopy, for endoscopic revision? So I would just say that really all of those avenues are open. Some patients come directly to me, some come directly to Dr. Sullivan. Obviously she has a lot of visibility in the university system. So some patients know directly of her services and come directly to her. And she's a bit more of a superstar in this regard that she has her obesity medicine training. So she does a lot of her own medication management herself. She doesn't need someone like me to help at all. So she does a lot of that on her own. But in terms of primary weight loss, primary care folks typically refer patients to me directly. And then really it's my job to determine, as I mentioned, do I focus on things myself with the patient or who else do I get involved from the standpoint of a dietician, sleep psychologist, someone else like that. And sometimes as it comes up in my discussions with a patient, maybe they're not interested in medication or they've tried medication. Maybe they're not interested in surgery. And usually as we go through kind of the list of things that we talk about for weight loss, if endoscopy comes up and it sounds like that's something that the patient's interested in, then it's time to refer them on to Dr. Sullivan. As far as surgical patients, some come to me from the community at large. Either they've been out of care for a while and are looking to get reestablished. Some come directly from the surgical center. Maybe they've done their followup with the surgeons, they're regaining weight. Maybe we think about medications. Sometimes the surgeons refer directly to Dr. Sullivan too. So really all avenues are open. And as long as a patient, I feel pretty confident, as long as a patient gets into sort of our system, whether it's through the surgeons, through the endoscopist or through myself, that if we aren't the right person to address their concerns off the bat, that we will get them to the person who can best address their concerns. Thank you. All right, and I think the next question is for either Dr. Masineni or Dr. Millard. So I think we've seen this graph a few times today where when you start a medication, weight loss, patients start having weight loss. And then they might start plateauing. And then that might be a time to switch to another medication. So from your experience, and just for obesity medicine doctors who are listening, when do you think might be a good time, like after how many medications that you think might be a good time to consider or bringing up bariatric endoscopic procedures with the patients? I'll kind of start and then have Dr. Millard add more. So when we start with the first medication, when I was talking about the strategy, if they do lose a 5% of body weight or if they lose kind of more than that, and they lose weight and then they reach a plateau, we do not switch medications. I want to be very clear about that. I add another medication. I do not take off the medication that has been effective. So in that case, I would be adding a second agent or sometimes one of the cases that I showed after a sleep gastrectomy, that patient went on three different agents sequentially. First on fentramine, then on topiramate, then on a GLP-1 agonist. So the thing is that there will always be a plateau that is a part of any treatment, whether it's endoscopic, whether it's surgical, there will be a plateau. And then there could also be a little bit of weight regain that comes after a plateau as a part of the biology of weight regulation. So we always use that and then we add other agents. Now for endoscopic therapies, there are the times when, again, we don't have an established endoscopic program within UNC yet. We're in the process of setting that up. But I work with another endoscopist in the area and I send patients to them. When we start talking about it and the people with a lot of comorbidities and a lot of exclusions for medications, and if they're not a candidate for surgery for whatever reason, the first thing that comes up is endoscopy in my practice. And again, when we start working with them, if there is any chance that they're not responding as well as we would hope, then we would want to go for something more aggressive. The problem that we face, which is gonna be different in other places where they have programs, which a lot of people who are willing to pay privately are able to come in, where there's no insurance, they're able to just pay out of pocket. There are some programs where they're well-established and the people come from all over the country to those programs. Here, a lot of patients have to depend on insurance. And since insurance does not cover a lot of the endoscopic procedures, I offer it to them, but in a lot of cases, we start the conversation early and we talk about it, but a lot of cases, the patients have not been able to afford it. There've been very few people who've been able to go on to that path. Thank you. Yeah, and I would say at Colorado, it really just boils down to the patient's preferences. We try really hard to listen to our patients and get a sense from them of what their priorities are. I can think of a patient just within the last month who I've been seeing for about a year and a half. She had had gastric bypass, had done very well, but had some life events that led to some weight regain. And when we first talked at our very first visit about the idea of doing an endoscopic revision, she was thoroughly opposed to it. She just didn't wanna deal with anything, anything surgery-wise, anything procedure-wise, just wanted to stay as far away from that as possible. And we tried phentermine and topiramate. We were actually very successful initially with weight loss, but she's had a number of life events during the pandemic pop up that have really made it more difficult. Personal injury, death in the family, job change, and she's seen some additional weight regain. And it's funny, she actually was so passionate about not wanting any type of surgical revision at our first visit that I had really moved that further down the list of stuff for us to revisit. And at this last visit, she was really frustrated with where she was. She said, we've been on medications for a year now. I just can't catch a break from a life perspective. And I thought this was really the time for us to bring up endoscopy again. And the minute I brought it up, she said, well, why didn't you mention that sooner? Well, there's a lot of negotiating that goes into that. But I just told her, I said, I heard how passionate you were at the outset, and I sort of put that back a little further in the hopper. But now that we're at the crossroads that we are, I think this really may be an option. And she jumped on it immediately, has already seen Dr. Sullivan, and they're likely gonna plan for a revision relatively soon. But I think the overarching message is, you can't push a patient into something that they don't necessarily want. And just listening to them and taking their temperature of where they are will really go a long way to guiding you on the best path for them. Love it, thank you. Yeah, always bring it up, but don't push them, right? Yep. Give them all the options. All right, Dr. Shuman, one more question. So you did a wonderful job listing all the nuance about the EDGE or GATE procedures. So do you mind telling us, like, what is your approach now? Do you prefer one, two stage? What techniques, just so that the referral doctors can understand what they can tell the patients, like, hey, this is not gonna be a one and done ERCP. Like, what is your current approach for this procedure? Yeah, that's a great question. And it's something that we've done a lot of thinking about at our institution to help sort of patient education, and then also help us sort of minimize any potential adverse events that could occur during these procedures. We're fortunate to work very closely with our surgical team at University of Michigan, and we get a ton of referrals for these types of cases. So I've thought through this quite a bit. I think in many ways, it's hard to predict, because the first thing that really matters is where you're accessing, either from the pouch side or from the blind limb or roux limb side. If I can do a gastro-gastric stent placement, I'm much more likely to drive through it on the same day, because the thickened wall of the gastric stomach and the remnant, I think allow for the stent to stay in place more so than if you are connecting from the small bowel side to the remnant stomach. The second thing that I usually tell people, so again, it depends on the patient, because sometimes you have a great view only from the blind limb or only from the roux limb, and there's not good access from the pouch. The second thing I tell people is it depends what size stent I place. And so usually if I can place a 20 millimeter stent, then I commonly will try to drive through on the same day, but again, it will depend on where exactly the location is and what my scope position is under fluoroscopy. So if I see that my scope is bending a lot and pushing against the side of the stent and I worry about dislodgement, then we won't proceed or we'll consider suturing the proximal portion of the stent to try to prevent migration. So there's many things involved. The other thing that I've started doing more commonly is not using, it's sort of preloading a wire, but not using the wire as I place the stent, because I found that the wire will sort of guide you one direction or another. And so what I usually end up doing is placing the distal end of the stent after preloading the wire and then gaining access to the remnant stomach just to make sure that I don't lose my access should the stent be dislodged in some capacity. And that has also helped me sort of dictate where I can puncture from and have a better option on fluoro for when my ERCP scope ends up being passed through it. So there's many things involved. I think it's probably in many ways, not the best procedure for someone with cholangitis, given the fact that there's the potential that you would place the stent and then not feel comfortable driving through it. We have done a handful of cases, fortunately with good results in that setting, but there are certainly times where I would want to, if it were just colodocalothiasis, want to abort and come back at a time once the stent is epithelialized. It always feels like a safer procedure. The other things that we do is if we feel that it's important to go through on the same day because of cholangitis, and if for any reason the stent were to migrate, we have started placing through the scope esophageal stents in that setting. So much longer stent that can be easily placed as long as you don't lose your wire access and can save a catastrophic event during an EDGE procedure. So many things involved. I have an algorithm that I follow, but I don't know what should come. It will depend on the patient's anatomy and where my access point is and what stent I'm using. Wonderful, thank you. So basically always consent for at least one, if not two or three procedures, depending on the anatomy level. Wonderful. Alrighty, so thank you very much for all of our wonderful speakers on this panel.

pharmacotherapy

bariatric endoscopy

obesity

weight loss

patient preferences