So, we will next go to Dr. Brett Peterson from Mayo Clinic, Rochester, who will demonstrate a disposable duodenoscope. Dr. Peterson. Okay. Greetings. Thank you very much. Hi, Todd. Hi. I'm Rita. It's fun to see you on camera and Raman. We're using a Boston Scientific Exalt single-use duodenoscope for this case, and given a little bit of delay here, we did intubate, and probably the most interesting part so far in the first few minutes is that a cricopharyngeus was a difficult area to pass, and so we did have to put a wire and a balloon down to the stomach, which worked very easily, but it's hard to know would that be the case with any other endoscope or not. It enhances or highlights the issue of caution with this instrument, especially if you're inexperienced with it, on traversing difficult areas. I'm going to ask our advanced fellow to give a brief summary of the case that we're well into over the last couple of months, but with ongoing challenges related to anatomy. Okay. Sila? All righty-o. Hi, I'm Sila Pissipatti. I'm one of the advanced endoscopy fellows here. This is a 66-year-old gentleman who initially presented to an outside facility with painless jaundice and pruritus, and following ultrasound and CT evaluation, he was found to have numerous stones in his gallbladder and a pancreatic head mass, which was proven to be adenocarcinoma following USFNA. He had an ERCP done locally, and a plastic seven French biliary stent was placed. In April, he was referred to us for further oncological care, had a negative staging laparoscopy, and was then initiated on neoadjuvant systemic therapy. He was referred to our group in May for an ERCP to exchange his plastic stent to a large caliber stent. RFA was performed to the distal biliary stricture, and a bare self-expandable metal stent was placed. In June, unfortunately, he developed pulmonary embolism and was initiated on anticoagulation. Subsequently, he developed right upper quadrant pain, had a CT that suggested features of cholecystitis with a potential leak from the gallbladder, and was referred for ERCP to interrogate that stent and for gallbladder drainage. So in June, he had the ERCP performed, and as you see on the images, there was some pus coming out of his bile duct. There was modest in growth of tumor into the bare metal stent, and a double pigtail stent, and two of them were actually placed via the cystic duct for gallbladder drainage. Following completion of his systemic chemotherapy, it was felt that he had good response and was taken to OR for more definitive surgical intervention. Unfortunately, in the OR, he was found to have unrespectable tumor with vascular involvement, as well as a perforated gallbladder with stones in the subhepatic space and gallbladder fistula into the colon. So he had a subtotal cholecystectomy, it was a very challenging procedure, and a segmental colectomy at the same time. And because of concern for potential gastric outlet obstruction, he also had a surgical palliative bypass done at the same time. Unfortunately, immediately post-op, there was concern for ongoing biliary leak, and his LFTs trended up, so he was referred back for an ERCP. At that time, the bare metal stent was found to be occluded, so he had a covered metal stent placed coaxially, and a lot of filling defects were noted on the cholangiogram proximal to that obstruction. Other stones and sludge were actually found. He had spyglass with electrohydraulic lithotripsy, as well as mechanical lithotripsy, but with incomplete clearance. He had double pigtails left into his right and left hepatic duct, in addition to those two metal stents that he now has. So we've just started the procedure, we've taken his pigtail stents out, and Dr. Peterson is about to go in to evaluate the bile ducts. So you can see he had no stones in his duct at the time of his initial metal stent placement open, and then subsequently, we can switch to our live case images. He subsequently had a duct full of stones after surgery, and I'm confident they were all expressed into the duct in the course of a very difficult cholecystectomy. We've just torn that, drop that off, okay. So we've taken out one pigtail stent, and this one feels a bit more intractably caught up above, and we're just using a snare to start, and we'll see if we can get a better grasp on it, or a rat tooth if this isn't successful. The exam of the surgical drains yesterday, which shows a small pocket with stones in it, was interpreted as just an abscess or recessed area, and let's switch to the rat tooth. To my eye, it looks like residual gallbladder that's still fairly full of impacted stones. So we don't have a good feel for how much stone burden will be above here, but the last images of the last procedure suggest there's still quite a bit. I was a little disappointed that three and a half weeks after the last procedure, you can see on the radiographic image that the self-expanding stent, the second one, has not fully compressed the ingrowths, and sometimes we find that that may not ultimately compress at all. I think I'll pull this back to the stomach and get it out of our way open. Right. Can you talk a little bit about why you're choosing an exalt for this case? Is that part of what you always use or protocol? That's a very fair question. In fact, we've participated in all exalt studies, open quote, but we are not yet a commercial customer. So yeah, you do have some metal. That was a request of us, of the course directors, and since we're eager to trial exalt amongst colleagues who have not used it, and to further consider our options for availability, we are using it on a short-term basis. So it's not specific to this case. But reasonable, if you think about some of the indications that are out there, immunocompromised patients, certainly liver transplant patients. In our center, this would fall under one of the patients that would be eligible. Yeah. Yeah. Same with ours. I mean, I think, as you mentioned, Amrita, you've got an immunosuppressed patient. They're also stenting, and we also tend to use it if they've got cholangioscopy, both because we actually think it helps perform the procedure, and as was kind of alluded to earlier, the risk of bacteremia from that procedure. So certainly, I think several reasons you could justify using it. Yeah. So since 2015, we've relied upon ethylene oxide sterilization after high-level disinfection for all duodenoscopes. We're still doing that and basically waiting for FDA review and comment on all the post-market surveillance culture studies for the most recent removable CAP scopes, and those are not all back announced and commented upon. They're sort of still being adjudicated with the FDA. So of our major sites within the Mayo system, one has a dropped ETO and is using the exalt scope on a PRN basis for high-risk patients, and the other two have not yet taken that step awaiting FDA's decision. So whether we continue with ETO long-term hasn't been decided, and in that environment, we've not felt it necessary to have a single-use scope in our armamentarium yet. Let's go ahead and score it. Brett, do you think that all of a sudden, we're not seeing the infections that occurred years ago? Is that because you think we're doing a better job at processing, or what do you think that is? Like all of a sudden, there aren't reports like there were of all these horrible infections? You can come up. We're not on camera. Yeah. I do think everyone's doing a better job. I think we're all more closely attending to education and oversight. Many sites are doing routine surveillance cultures down a little bit on the balloon. So I do think it's a change in practice nationwide, probably worldwide, that's making a difference. Raman, are you using ETO yet? Yeah. We were on ETO for, gosh, about eight or nine years. We just went off of it about a year ago, Brett. I think Todd, to answer your question, I think there's no question we're paying more attention multiple steps. We also have revised the reprocessing because we have the brush, and even if you're just doing standard and then many people are doing augmented, like Brett's doing ETO, or some people are doing double HLD or various things. And then just to go to the disposable tip, there has been some preliminary data from one of the manufacturers that showed a 90% reduction in the number of contaminated devices that they were seeing. It went from about 5% to 0.5%, but we wait the other manufacturers. I will comment, there was a trial that you may have read called IceCap study that was in JAMA, which interestingly still found a 4% contamination rate, not bacteremia, but contamination rate of pathogenic bacteria. And interestingly, in that study, most of it came out of the instrument channel. So the tip was getting fixed, but there were still some contaminants. So I think certainly progress, but I think still some potential, I think. Yeah. So Brett, do you think your wire is in that gallbladder? Yeah. Yes, I absolutely do. And ultimately for him, what would be a good end result? This gentleman has unresectable cancer, but he probably has a fair lifespan yet with modern chemotherapy. So I think the important thing for his life comfort would be to get rid of his percutaneous surgical drain, which he's not done yet. You can see it in the background there. And that yesterday showed communication to this residual gallbladder. So if we could establish wide open drainage distally with or without removal of everything in the gallbladder, I think that would be to his great benefit. And ultimately we're going to go up higher in the common hepatic duct, which I suspect also has stones, but I'm not going to try and bite off all of them until we clear the easy ones at the bottom. I know you've had a lot of EHL today, I suspect, so I'm hesitant to go straight to that. One of the interesting points, I guess, would be the ease of use of EHL through an exalt scope. Mechanical lithotripsy would be a good option. I'm a little concerned about catching the top of the stent, but at this point I'm inclined to take it out, the inner stent, and see how nice a channel we have without it in place. I wonder for this patient too, if you end up not being able to clear, you know, if he really has a kind of fossa collection, there was a mention of like stones sitting up under the liver, if that doesn't all kind of form a cavity that, you know, eventually after removing that percutaneous tube, you could even look into EOS guided into that space if it, you know, used to be a problem. Yeah, I was thinking the same. That's a good point. I hadn't had the impression that that was still an active concern in post-surgical findings and resolution of much of his disease. We have two stents here. I don't want to grab the outer one. They're both similar design. One's coated and one's bare open. Well, I guess we grabbed the right one. And I think it will be open because it's just like the stent and stent removal technique. You're probably going to have necrosed most of that tumor in growth and he'll do okay for a while until he gets more in growth again, I would think. I'd be happy to leave them with a coated stent terminally or whenever that happens. I think it's a good idea. My own practice is to start with a covered stent. And I know the data is quite mixed, but our data suggested better or longer patency results with covered and others don't find that. I'm not impressed with migration rates, although that's the counter argument for these stents. Are there differences amongst you about first stenting in that setting or it's part way? My sense is, and I could be wrong, is that more and more centers are doing upfront covered because if you don't do on-site pathology at your FNA or FNB, like my approach is I don't do on-site pathology. I do all FNB, but I don't commit to an uncovered stent in the absence of a final definitive tissue diagnosis. And I wonder if that's what's leading maybe more covered stent, but that's a total hypothetical. I don't know that. Brad, can you comment on the maneuver that you just... Yeah. So removing a metal stent that's covered is usually very easy, but it requires some attention to whether it's fully intact and might have some ingrowth if it's been there a long time. The other stent with barbs on the sides occasionally are fairly traumatic when they're removed. So I like to grab the stent, pull it down as much as I can with a snare, and then work my way up, choke up higher, let go, come up higher and higher until I'm almost at the midpoint. In this case, it was very obvious it was going to slide easily, but if it's not, sometimes it's almost like a stone removal technique where we're pushing it down into the distal duodenum. You clearly don't want to pull it around the corner at the apex of a sphincterotomy, partly because of risk of getting caught there and partly tearing some of these stents or can be torn if they're pulled against a lot of force. But if they're pulled straight down, either they come easily or you work on the outside around it. I'm going up here. Let's put some contrast in here and understand this stent a little more. That's a pretty wide open picture there. And let's see if we can see the top of it. Let's put our scope below it. And squirting. There's probably stone material right there. Okay, make sure. Nice. Let's put a a 10 millimeter dilating balloon up here, down. I'm just going to dilate that small short stricture just above the stent, and then we'll take a moment and see if some of this is all small enough to come through or if we need to use a lithotriptor of one variety or another. I'm going to throw it back to Todd promoting your EOS guided practice, but this patient's now undergone numerous ERCPs and that duct looks like it's completely packed. At what point would you consider doing a hepatic gastrostomy on the left side just to establish drainage for this patient as opposed to planning to continue to try to clean him out? Well, here's the other thing, Brett. How long has he gone? He was asymptomatic with the stents in place? When this past three weeks since he's had put in place, he was hospitalized for three days with fever at home. Okay, got it. So he hasn't been totally paliated, if you will, with the plastic stents. I don't think that would serve him adequately with his current stone burden. He had a surgeon a couple states away saying he'd love to try to get him out, but he didn't think he could. So the patient, I think, wisely declined that opportunity. Go ahead. Okay, okay. So our goal here, I know you have other cases to move to, and this is transpiring from my standpoint as though I was using any other reusable endoscope. If we were examining something highly focal with neoplasia or something at a papilla, it might be a different matter. But this is exactly perfectly functional, as all of you know, in your practices. And come on down. Brett, nowadays, what percentage of patients can you not complete a planned procedure with the exalt that you have to convert to a traditional? So that has, there must be eight or 10 studies now, including the most recent international kind of aggregated study of 500 some patients from in press since about July, I think. Marco Bruno, first author, is consistent with all the prior studies of about a three or 4% conversion rate. And I think that one might've been 2%. Completion was not the same, but I think that was not scope related in all cases. So I think conversion to a regular scope, it's hard to know, is that because of a shortcoming of this instrument? Or is that because of a lack of confidence in this instrument, if you've used it 10 times and the other 100 times? Sometimes it's really the pathology. Yeah. The pathology of the endoscopist. Yeah. Well, the combination. Go ahead, go out. Yeah. And it doesn't even appear to be experienced. There's a previous, as Brett mentioned, there's numerous studies. And one sort of compared someone who, people who had done more ERCP to less. And in fact, there was actually a numerically lower number of conversion in the less experienced people. Maybe they were more persistent. I'm not sure. But I think that even among operator experience, it doesn't seem to vary that much. Raman, have you noted any particular cases where it's been helpful? Is it open and slightly slimmer? You know, and I be curious as you're in, one of the things that has been mentioned many times is that the scope is stiffer. And that sometimes helps you in patients who've got that J-shaped stomach that you may have to normally roll, et cetera. I find that I'd have to do less of that. And then I think it's also helpful when you've got a cholangioscopy. I think it's actually, it was interesting in the very first version of this, Brett may remember, it was really difficult to push a stiff object, a cholangioscope, a metal stent. And I was actually watched how easily you just remove that metal stent, Brett, just right through. That was probably in the first version, not that easy to do. And actually it's gone to being our preferred device now for cholangioscopy cases, not only because cholangioscopy is associated with a level of bacteremia, but also because we actually think it just physically is easier to do. I don't know if you've had that experience, but I think it's a little stiffer. It allows you to drive up. It's also a little bit more stable. And so I found some advantages with that. I'd be curious, Todd, Brett, Rita, your thoughts. Yeah. Well, as I mentioned, we're not using it commercially yet, but there's been a tremendous change. And that's the nice thing about these single use devices is the rapidity of iteration. This is about the fifth iteration and it's now generation three marketed. Come on down. We have not adopted in our practice. So I don't have experience with it. Yeah. I found that it's been helpful, particularly if there's some duodenal narrowing right in the bulb, or if there's an indwelling duodenal stent in getting through. I've had a couple of cases. And like you said, Raman, with the real J-shaped, the stiffness is there. I haven't particularly noticed the stability with the clangioscope, but I can see that oftentimes part of the problem in really getting proximal into the intrapadics is that you fall out into the stomach. And I could imagine that that would be a little bit more stable with the stiffer scope. Do you do your ERCP supine or prone? I do mine prone. I don't know what the rest of you are saying. I do. I do them all. I've been doing supine ERCP for like 15 years now. Yeah. Same here. But the reason I mentioned that is just the stability issue. Sometimes when you're supine and you're doing clangioscopy, there's a little bit of more of a stability issue. That's why I asked. Just curious. Yeah. No, especially at the distal duct. I mean, one of the big changes with the new SPI system with the distal chip is that you can evaluate the distal duct better without falling out. And I wonder if that's even more improved with this. Yeah. Oh, sorry. Okay. Yeah. Well, one final point I would just make is that I think single use can go beyond just infection prevention into specialty scopes. You were talking about doing supine. There are prototypes now that are actually rotatable, so you don't have to rotate yourself. You can actually stand in your normal position. There's forward viewing scopes with side views so that in a tight stricture from pancreatic cancer, you can kind of navigate like an EGD scope and then click a button. So I think we're going to see some nice innovation that goes just beyond infection prevention. Thanks, everyone. Thank you, Dr. Peterson and the moderators for a great discussion and case here. Thank you. This concludes session one.

video

Dr. Brett Peterson

Mayo Clinic

disposable duodenoscope

ERCP procedure

pancreatic cancer