Welcome everyone. Thanks for coming. The American Society for Gastrointestinal Endoscopy appreciates your participation in tonight's webinar. My name is Lauren Loading, Manager of Evidence-Based Guidelines and Documents at ASGE, and I will be the facilitator for this presentation. Our program tonight is entitled ASGE Guideline on the Role of Endoscopy in the Management of Malignant Hylar Obstruction. Please note that this presentation is being recorded and will be posted on GILeap, ASGE's online learning management platform. You will have ongoing access to this recording in GILeap as part of your registration. I also want to acknowledge the educational programming support from Olympus for the remainder of our 2021 ASGE Thursday Night Lights series. Before we get started, please note a number of features in tonight's platform so you are aware of the many resources available to you during and after tonight's program. Currently, you are all located in the auditorium. As you enter the lobby, you should note meeting information, which has tonight's agenda. There is also a satellite symposia section with recordings you can access. In the resource room, you will find a number of options, including Video GIE Meet the Master videos, the history of endoscopy section, a gaming section, as well as access to ASGE guidelines and GILeap. In the networking lounge, you will find an access link to complete an evaluation survey for tonight's webinar. We'd appreciate if you could complete this, it only takes a minute or two. Finally, I would like to guide you to the virtual exhibit hall, where there's a number of exhibitors providing information and resources, including an ASGE booth. If you have questions, swipe your virtual badge and a representative will get in touch with you. These features are available to you during the webinar and any time following the program. There's a URL link, learn.asge.org. That is where this recording will be located in a day or two. Tonight's objectives include a review of the guideline recommendation statements, discussion on how to implement recommendations into your practice, and time to answer participant questions. Please submit your questions through the Q&A box, and after each recommendation, we'll take a few minutes to go through those. Our moderator for tonight will be Dr. Laith Jameel. Dr. Jameel is the section head of gastroenterology and hepatology at Beaumont Health. He's also a professor in the Department of Internal Medicine at Oakland University, William Beaumont School of Medicine. Presenting tonight's lecture will be Dr. Bashar Qumseh. Dr. Qumseh is an associate professor and associate chief of endoscopy at the University of Florida, and he is the chair of the Standards of Practice Committee for ASGE. He is the lead author on the guideline document being presented tonight. One quick final note, you do have full access to all of our guidelines through the GIE journal, and also on the ASGE website at asge.org under the tab ASGE Guidelines. Now it is my pleasure to hand it over to our moderator, Dr. Laith Jameel. Good evening, everybody. Welcome to the second webinar from the ASGE Guidelines on Thursday Night of Lights. We will be going over the guidelines mentioned, which are the ASGE Guidelines on the Role of Endoscopy and the Management of Malignant Hyaluronic Obstruction. This is the second of the series. The goal is obviously to not only raise awareness about the new guidelines that have been published, but foster an understanding of what evidence-based recommendations are and how they come by, so that you know why these recommendations came about and how, as you implement them in your practice. It also gives an opportunity for the physicians to ask questions about how this process came by, how these guidelines were developed, and why our final recommendations are what they are. So the aims of the clinical practice guidelines, they serve many aims. One is guiding decisions based on the best evidence out there. So this is not just an expert opinion. This is not just one person's opinion. It's what the best evidence shows. It also helps standardize patient care. It also improves provider performance and reduces variability in the practice. Our process, our guidelines, the process, follows a very rigorous process. It's based on a systematic review of medical literature and a great methodology. So the recommendations are based on many, many considerations. So it's not only the scientific evidence. We take into account what cost effectiveness is, equity, feasibility, and acceptability, not only to the medical profession, but to the patients and to the whole system. We also take into account adverse events from all these interventions. And last but definitely not least, the patient's values in this whole process and the interventions that they're going through. So with that, next slide, please. Remember these guidelines are not a substitute for the physician's opinion on an individual patient. This does not apply to everybody. At the end of the day, our role as physicians is to take these guidelines and see, do they apply to the individual patient? And if they do, great. And if they don't, then we modify it accordingly. The final decision of any intervention should always be based also on the local expertise and patient's preferences. As you'll see in these guidelines, when we talk about various types of interventions, you have to say to yourself, does this hospital have this intervention? Or does it have this expertise? Do I have this expertise? Or is someone else more capable? So with that, Dr. Kamsia will take us through the guidelines and the PICO questions and how we came about our recommendations. Dr. Kamsia? Good evening, everyone. We are sorry about this technical difficulty here. And it is my pleasure to meet you again today as we talk about our guideline. All right. So our guideline was recently published in GIE. Again, you have free access to all ASGE guidelines without subscription to GIE. Please go to our website, asge.org, and there you'll have all our guidelines. As a background, malignant hilar obstruction can occur, as you know, from several types of malignancies. Primary tumors, Klatchkin's tumors involving the hilum is the most common, but we also see local extension of gallbladder cancers or other adjacent cancers. Metastatic involvement of lymph nodes causing hilar compression as well. Now, we all know that there is very poor survival with a five-year survival of less than 10% in this patient population. Most of the patients, unfortunately, at presentation are unresectable. And if they are resectable, surgery usually involves partial hepatectomy or liver transplant patients. And most patients, even the unresectable ones, require some form of biliary drainage to relieve symptomatic pain or jaundice, prevent adverse events like cholangitis and itching, or for perioperative assessment and also to preserve the liver function. So a lot of these patients, even the unresectable, do require drainage when they're obstructed, obviously. And so for this, we had three main questions, which are listed in our table three in the main document. And we will go through each of these clinical questions and tell you the evidence and the discussion we had and the final recommendations. After each question, we will take, after each PICO question and recommendation, we will take questions in the Q&A. And so this is meant to be interactive. So please do ask questions as they come up. And Dr. Jamil is going to help us answer those questions. So we are following the GRADE methodology, which is a grading of recommendation, assessment, development, and evaluation. And everything here is based on systematic review and meta-analysis for each specific question. Our panel included SOP members, independent content experts, hepatobiliary surgeon, interventional radiologist, and a patient advocate from the Cholangiocarcinoma Foundation. And we thank all of them for their help. We couldn't have done it without the panel. In table four and five, we describe to you what the quality of the evidence means when you have quality of evidence described as high, moderate, low, or very low, and what it means. And in table five, we describe to you what a strong recommendation means and what a conditional recommendation means. The take-home point, a lot of people ask me, what does a conditional recommendation mean? Well, for patients, it means that most patients in this situation would still want to have the suggested course of action, but many patients may not. So it's still a recommendation, obviously not as strong as a strong recommendation, but it's still most people would want to have this suggested intervention if we have a conditional recommendation. Our searches are done with the help of an expert librarian, and we use existing systematic reviews, and then we can update them. So without more about the methodology, you can read more about the methodology in our document. We will start with the first question, which is what kind of stent should I use? Should I use a metal stent, self-expandable metal stent, or should we use a plastic stent? And so in patients with unresectable malignant hyaluronobstruction undergoing palliative endoscopic drainage, what is the role of Biroy-Sem's self-expandable metal stents compared to plastic stents? And so let's look at the evidence. We started by a systematic review by Sarwas and colleagues from 2015 and used only comparative data from that meta-analysis. We found three RCTs and two cohort studies. We then updated the literature search and found three more cohort studies, which we added. So the first outcome we looked at was the outcome of survival. And in this here, you see the forest plot and the difference in the mean of survival in days. As you will see throughout this presentation, we'll separate the evidence from randomized trials and retrospective studies, but we'll combine them for you to look at. So if you look at the evidence from the two randomized trials that looked at the mean difference in the number of days the patients were surviving in SEMs compared to plastic stents, there was a significant difference in 56 days more in patients who had SEMs compared to plastic stents. If you use the data from cohort studies, i.e. retrospective studies, there was not a difference. Once we combined the RCTs with the retrospective studies, the difference was not significant, but it was very close to being significant as the lower limit was negative three days. So that's what the outcome of survival. What about the outcome of stent patency? Here we again looked at two RCTs and five retrospective studies and looked at the standard mean difference for improvement in stent patency. And again here we found that the stent patency was significantly better in the two RCTs if you compare metal stents compared to plastic stents. This was also true if you looked at the five retrospective studies or if you combine them all together. So significant trend toward, I mean significant difference in terms of standard mean difference for improvement in stent patency. So improved stent patency, this evidence was considered to be moderate in quality. As far as the rate of reintervention, here we had three RCTs that contributed to this and five retrospective studies as listed here. And in the three RCTs, the odds ratio of reintervention rate was significantly lower, 0.18 for stems compared to plastic stents. So if you had self-expanded metal stent, you were less likely to have reintervention. And the same if we looked at evidence from cohort studies, as you can see here. This evidence was also rated as moderate in quality. Other outcomes we looked at was insertion success. How successful were we in putting stems compared to plastic stents in three RCTs? So that there's no difference in putting stents and or plastic stents. We were equally as successful. Drainage success, as this is defined in more studies as a decrease in the total of a little bit by 75% in four weeks. In one RCT and four cohort studies, showed that the drainage success was higher in stems compared to the plastic stents with an odds ratio of 0.82. And for the outcome of adverse events, there was no difference in 30-day mortality, cholangitis, or pancreatitis between the two groups. What about other considerations? We looked at cost and stems obviously are more expensive, yet they have lower reintervention rates. So for cost effectiveness, we did not find any studies that assess cost effectiveness directly between those two groups. There was a study from GIA 1999 that assessed any obstruction, not just malignant tiler obstruction. And in that study, they found that initial plastic stent followed by self-expanded metal stent was the most economical option. Again, this is not specific to malignant tiler obstruction, but we do mention it here and we did discuss it as well in the panel. Patient values, there was no studies assessing patient values with regards to this question. The patient advocate in the panel placed a high importance on avoiding permanent stents if reintervention was hard, i.e. some panel members thought that if you place a metal stent and you needed a reintervention, it is hard. And the patient advocate did not like that. As far as equity, we thought that stems may not be available in some resource-poor settings. And so that's a consideration to think about. What are other considerations that we had a significant discussion about? So we showed some evidence that there is improved survival and improved stent patency. However, the panel was hesitant. And the patients in the randomized trials who had plastic stents did not undergo scheduled stent exchanges like we would do here. They just had a plastic stent and then were followed up. And thus, some in the panel were questioning whether the data behind the survival approval in the stems was actually accurate. Exchanging plastic stents, like we said, is a lot easier than re-stenting an occluded stent. And this was actually supported by one of the cohort studies. And then several people on the panel were concerned that many open-access patients may not have definitive answers at the time of initial ERCP. And thus, if we decide to have a strong recommendation for stems, this could be disadvantageous for some of these patients. So the final recommendation was, in patients with unrespectable malignant hyaluronobstruction undergoing palliative stenting, the panel suggests placing stems or plastic stents. Conditional recommendation, low quality treatments. However, when should you think about one versus the other? If you have patients who have a short life expectancy, less than three months, or who place high value on avoiding repeated interventions, they do not want to come back or schedule stent exchanges, then we would suggest that you do self-expandable metal stent, not the plastic stent. On the other hand, if you are not clear about the optimal drainage strategy, or don't have the final diagnosis, you're not sure which side should be doing more than the other, you don't have all the answers at the time of your first visit, then the panel would suggest placing a plastic stent, or two plastic stents, as we'll see in the next recommendation, rather than metal stent. So those are the recommendations that we had. This is the graphical recommendation again. So if you have short life expectancy, or the patient prefers to avoid repeated interventions, then you should use self-expandable metal stents. If you're not really sure about the optimal drainage strategy, or the final diagnosis is not really established, maybe it's an open access case, we suggest that you do plastic stents. If neither of these cases is right, then either choices, whether you put a self-expandable metal stent or plastic stent, may be fine. So that was great. That really summarized all the panel discussions and all the evidence that were behind the guidelines. At the bottom of your screen for the participants, there's a Q&A, and there's a chat option. So please, if you have any questions, just put them there, and we'll be happy to answer them. So while we're maybe waiting for a question, I'd like to, you know, elaborate on what Dr. Kamsia said about why, you know, the evidence suggests a kind of a strong recommendation, but the final recommendation was not. Obviously, we had a patient advocate who, you know, gave input also, which swayed us. And several of the experts, if you will, who do this on almost a weekly basis, have noticed in our individual practices that the longevity of these patients now is not what it used to be when this literature came out, you know, five, six years ago. Now patients, if you are able to get good biliary drainage and bring the bilirubin down, they're getting chemotherapeutic agents, there's some luminal therapies, and their longevity now is hitting a year, some a year and a half, some even longer. And while you look at the studies that were published, you know, probably three months, and for plastic stents was maybe a month or two. While a lot of us have patients that we routinely exchange these plastic stents every three months, and they live for a year or two with chemotherapy. These, we're talking about the unresectable. Some are resectable in the beginning, and then, of course we find out they're not. And so the practice is changing. I think with time, more data will come out to support this. But again, looking at the studies in detail, if you don't change the plastic stents on a regular interval, they will clog, they will cause an infection, then the patients get cholangitis. And we believe that's probably why it contributed to the higher mortality rate in these patients after two or three months compared to the plastic stents. So the metal stents, of course, their occlusion rate is lower on the short-term. So I don't see any other questions, nothing in the chat. Dr. Kounsia, do you want to add anything before we go to the next people question? No, that was excellent explanation. Like, you know, like you said, we had some strong evidence to suggest the stems, but things have changed a bit and that's important to recognize. Please feel free to ask questions if you have any, otherwise we would move on to the next question. And of course you can continue to ask questions if you have in the Q&A answer. So the next question we wanted to assess is the drainage strategy. Should we do bilateral stenting or should we do just a unilateral stent? So in patients with unacceptable malignant hyaluronobstruction undergoing palliative endoscopic drainage, so the same patient population as with the previous question, what is the role of bilateral stenting compared to a unilateral stent? And for this, we started a new literature review. We identified six studies, including three randomized controlled trials and three retrospective studies. All of these studies were about unacceptable patients. Two of the studies assessed the stent by stent technique, where you put two stents next to each other and one study looked at the stent in the stent technique and two studies used either or both at the same time. Depends on the patient. So the first outcome, as you will see, is survival. And this is a study, a recent RCT, 2017 from South Korea by Dr. Lee and colleagues. And they found that bilateral stents improved survival. As you can see from the Kepler-Meier curves, bilateral stents on this side, unilateral stents, and the log-rank test was strongly positive. Adjusted hazards ratio on Cox regression analysis was 0.42 and it was statistically significant. Well, this evidence was rated down because it was only one study. And so we ended up with a moderate quality of evidence against showing improved survival in bilateral stenting. When we combined data from the two RCTs and two cohort studies and pooled them together, we found that the pool difference in the mean did not treat statistical significance. But again, this is unadjusted and this study here is adjusted for different variables. So a stronger evidence suggesting that there is survival benefit for bilateral stents. What about stent patency? Again, the same randomized trials by Lee and colleagues showed on multivariable Cox proportional hazard modeling that bilateral stems were associated with stent patency. Again, bilateral compared to unilateral here. With adjusted hazard ratio of 0.3 and it was significant. Evidence also was rated down because this was a single study giving us moderate quality of evidence. There was another randomized control trial from 2013, however, that showed no difference in stent patency. In terms of cohort studies, higher stent patency was noted in bilateral and two studies. And one study showed no difference in stent patency. What about success rate? We found two RCTs and two cohort studies. They both, when we combined data from the two RCTs and also combined with the cohort studies showed that there's lower success rates in bilateral stenting. As you might guess, placing bilateral stent is somewhat harder than placing one stent. And sometimes it could be difficult to get into the other side. So there was slightly higher success rates for the unilateral stent compared to the bilateral. What about the odds of drainage success? Again, drainage success, meaning that reduction in the total bilirubin by 75% in four weeks in most studies. And two RCTs and one cohort studies, as mentioned here, showed no difference in drainage success if you place bilateral stents or unilateral stent. What about adverse events? Early adverse events, there was no difference based on the two randomized control trials or when adding evidence from two cohort studies. Late adverse events, there was also no difference, again, based on two randomized trials or when adding evidence from two cohort studies. So no difference in early or late adverse events with either strategy. Late stent occlusion rate was also no different in two randomized control trials or when adding data from two cohort studies. What other considerations? Like we said, what about cost? Our judgment was that there was a negligible cost saving in bilateral stent or unilateral stent, no difference. What about cost effectiveness? There was no studies to inform cost effectiveness and none of the RCTs discussed the cost effectiveness of these different strategies. In terms of patient values, again, we had unfortunately no data. The patient advocate who was on our panel mentioned that most patients would place a high value of stent patency as it would require less frequent intervention. And there was also an emphasis on drainage success as it will allow chemotherapy to be started, which the patients feel very strongly about. So to summarize, bilateral stenting were associated with increase in survival and duration of patency and successful drainage. However, bilateral stenting was associated with lower technical success. Similar adverse events to both. Other panel discussions and deliberations where all studies assess patients with unreceptive and malignant hyaluronic suction, and therefore our recommendations are mainly for this patient group, which represents the majority of patients. We expressed concern that survival was mostly, as you have seen on the study from South Korea by Lee and colleagues, and that placing a strong recommendation would mean that most endoscopists would have to place bilateral stents. And some endoscopists may feel like they lack the expertise to do so, especially if it's a complex malignant hyaluronic suction in a community setting. So there was a discussion, should we do bilateral drainage or multisectorial drainage? Left anterior, I mean, right anterior, right posterior, and left side. There was no significant studies assessing that, so we did not discuss the significance. There were some discussions about stent-by-stent or stent-in-stent. A cohort study found no difference in success rates, but found that the stent-by-stent was associated with higher adverse event rates and obstruction rate, again, in a cohort study. Another cohort study found no difference in success rates, adverse events, or obstruction between the stent-by-stent and stent-in-stent. So for now, the panel felt that either technique may be used. There's some data on ARF-A and PDT through SIMS, and however, the data was not ready for making a recommendation, and therefore, we decided not to make a recommendation on that, but if that is available, you could certainly consider using it. So our final recommendation, in patients with unresectable malignant hyaluronic suction undergoing palliative stenting, the panel suggests placement of bilateral stents compared to a single stent. It's a conditional recommendation with low quality of evidence. Again, this is our graphical recommendation. You see here, we recommend bilateral stents is recommended more than unilateral stent. This is a brief case presentation to illustrate some of these recommendations at a 58-year-old white male, sorry about the typo here, who presented with jaundice and was referred to us for ERCP. Initially, ERCP, as you can see, showed hyaluronic stricture suspected for malignancy, however, a diagnosis and treatment plan was not established, so the plan was to place a plastic stent, in fact, to place two plastic stents, so we placed one on the left, one on the right side, as you can see here. Once the final diagnosis was confirmed that this is a cholangiocarcinoma, and based on discussion with oncology, the patient was not found to be a surgical candidate, and therefore, we brought the patient back, took the plastic stents out, and put in two bilateral self-expandable metal stents on the right and on the left, and this is a stent-by-stent technique, not a stent-in-stent. And that's it for the second PICO question. That was excellent, thank you. Again, if you have any questions, or in the chat box, please. A few practical points on this, you know, it's imperative before you embark on anything like this is to have as high quality in imaging studies as possible, because you do not want to be draining an atrophic liver segment. So if you've got, let's say, the left side of the liver is atrophic, there's really no sense of putting in a stent into an atrophic liver. There's not producing any bile, there's nothing to drain. You're actually exposing the patient to possibly infection with no added benefit. So imperative to get your imaging studies, make sure that you know which ducts you're gonna go after when you drain, especially if you're gonna do bilateral or multi-segment, and that they're not atrophic, and that you're functional. The goal is to, you know, drain more than 50% of the viable liver. So that's a key. And when you're doing bilateral stenting or more, antibiotics are always important in our opinion, I think, because there's a good chance you may be injecting contrast into some liver segments that you may not drain as well as you'd like. And so it minimizes the risk of cholangitis. And that's a nice demonstration on the images there. So I don't see any other questions. Dr. Kumsee, anything to add on practicalities of these, especially with, especially, you know, a lot of these patients present to regional hospitals, not tertiary care centers. Sometimes we'll get these patients and, you know, a lot of places don't even carry a 12 or 15 centimeter plastic stent. I don't know if you recall what stent you put in this patient, but it looks like it's almost a 15 centimeter stent. And so sometimes the patient may, you know, somebody may inject a duct and put in a 10 centimeter stent, think they'll make it, and now they're not draining it well. So you've got to make sure you've got the right length of stents and large stents, et cetera. That's all very, very good points, Laith. In fact, what we started doing in these guidelines is we put table one, which is these recommendations that we are discussing now, but in table two, what we call general concepts in the management of whatever disease the guideline is about. And there we discuss limiting the, and we'll go through some of them, but Laith, you went through some of them very nicely, limiting the injection of contrast and maybe considering perioperative antibiotics and not draining atrophic sites. So those are all good points. The length of the stent is key here. Remember here, in this particular case, we're dealing with a higher malignancy and the cholangiocarcinoma, Klatschgen's tumor. So we actually did not have, the plastic stents were 15 centimeter, as you mentioned, but we did not have even 12 or 15 centimeter. This kind that we put in is the silver uncovered metal stent. And so actually this does not go trans-papillary. Ideally you would want it to go trans-papillary, but if you cannot and you have to do it, you can certainly, the obstruction is above the papilla. So sometimes we do that if we don't have stent availability. I like, you know, I'm not sure about you Laith, I like these silver metal stents because they're small and you can put both of them next to each other but kind of start deploying one side, a little bit on the left, a little bit on the right, and then until you deploy them together. Because sometimes if you put in a stent and then you try to slide another stent next to it, if you fully deploy, let's say the left side, and you try to deploy another one on the right side, sometimes it can be difficult to achieve that. What do you think, Laith? No, I agree. I mean, yeah, the metal stents aren't long. I was obviously referring to the plastic stents. You got to make sure, especially if it's the first time and you don't have a diagnosis, as you mentioned in the guidelines, if you don't have the diagnosis established, you want to avoid putting in a metal stent. Once in a while, you know, I've had patients that actually had lymphoma then they presented with this and they responded greatly to chemotherapy. And we actually had to remove the plastic stents and they did fine. Sometimes you'll get a breast cancer metastasis that responds great to chemo. So it's imperative not to put in, in my opinion, a metal stent, a permanent metal stent in these patients before you know exactly what you're dealing with and that they're not operable. And that's what the patient wants. You know, my frame of mind of thinking for these is I'm a plastic stent kind of guy. And, you know, but I agree with you. These stents, I've seen them, they were great. And they allow you to put in two next to each other without going through the stent and securing the track. And you know for sure that you're in the ducts that you want to drain. The through and through sometimes can be a little bit challenging because you go through the stent and you're not sure if you're in the duct that you want. So- Do you have any tricks on getting to both sides? What kind of tricks do you think? Sometimes as we have seen, obviously the success rate is significantly lower. Most of the time we can achieve them, but it may take time. So what are your thoughts on what do you do if you can't get to one side? Do you have anything that you can tell us on how to do or how not to do it? So what I usually do after I, you know, cannulate and get in and all that stuff, as usually I'll get one wire and hopefully one wire will go into one of the ducts that you want. But for me to access a particular duct, my go-to wire is the short curved glide wire. And I use a long catheter system. So for example, a stone extraction wound, that's a long wire. And through it, I put in the short curved glide wire and I manipulate it. And it's very, you know, you can manipulate it, rotate it to get into these ducts. And I've been fortunate enough to, you know, get in most ducts that I need. I don't inject. I try to get a wire up. And then I compare it, of course, to the MRCP images that I have. Once I'm in a ductile system that looks like that's what I want, especially if it's curved. So if you've got a curve on the end and it's curved, you know you're in a big duct because obviously the curve has to be big enough to, the duct has to be big enough to accommodate the curve. And then after that, I then advance the catheter over the wire and I do just a very small injection. And obviously if you see the duct is large, that's it. Now, then I take out that short wire because I have a long catheter and I put in a stiffer wire, usually when I'm doing multi-segments, you know, three or four stents, then I go to a two, five wire, not a three, five, because then I can at least put in three stents, 10 French at the same time. And so then I'll exchange it for a long wire. And then I take the catheter out and do an exchange, dilate, brush, biopsy, et cetera. One other trick is if you're doing multiple stents is dilating in between. So after I put in one stent, before I put in the second stent, I'll advance a four millimeter or six millimeter hurricane catheter and any other catheter, but, you know, a biliary catheter and I dilate the track again. And especially if I'm putting three or four or five stents, then towards those stents, the end ones, it's imperative. Otherwise you won't get a stent and you'll end up pushing the stent into a biliary or having a hard time. But that's kind of- Yeah, excellent tip. Sometimes I notice I don't have this wire that you use. We have different, obviously everybody uses different wires, but it does help sometimes. Most people have more than one wire. Sometimes I notice that if one wire doesn't work, I will try a different wire. I'll try to reposition the scope differently. If I'm using a balloon, I'll try to inflate the balloon, deflate the balloon, kind of see if that affects the direction of the wire. So there are different tricks you can use to try to get to it. You know, if you put enough time, most of the time you can get it to the right time. The problem is we're all very busy. We have very busy schedules and sometimes you don't have another 30 minutes or you don't want to spend another 30 minutes. And I think that's most of the times that maybe you cannot do it. And in which case we recommend that you do that if you're specifically, if you have injected contrast into a certain ductal system, then you should definitely make sure that it is adequately drained. Yeah, absolutely. I avoid injection as much as I can until I'm in a duct. And like you said, if you're using a sphincter dome, you rotate the sphincter dome. So you just use different tools, whatever you have to get into the duct that you want. Okay, let's go to the last people question. All right, again, guys, if you have any questions, please go ahead. This is meant to be interactive. We may not see your name, so just feel free to ask any questions or just tell us about your experience with these kinds of recommendations that we're making. Would they work? Would they not work? What do you think about it? All right, the next and last question that we addressed in this guideline is a drainage modality. The question is, should you do endoscopic biliary drainage? Most cases here, we were discussing ERCPs. There are other options that this guideline did not focus on. And patients with standard anatomy, we're mostly thinking ERCP or percutaneous biliary drainage, PTBD. So the question is, in patients with malignant hyaluronic suction undergoing drainage, what is the role of endoscopic biliary drainage compared to PTBD? And so for this, we started with the literature search and found a systematic review by Liu and colleagues from 2018. The search was updated from 2017 and up. In total, we identified three randomized control trials. One from the Netherlands, which was stopped early due to higher mortality in the PTBD group. One from India from 2008. And there was a US-led multicenter study by Munzer and colleagues who was on the panel member with us. And this was terminated prematurely due to low recruitment. There were eight retrospective studies addressing this outcome. So again, with the outcomes we are discussing, we found, we looked at early mortality. This is post-procedural mortality within 30 days. This was reported in all three studies. And there was a trend toward lower mortality in the ABD compared to the PTBD group. You see, this was significant for the Netherlands group. Like we said, the patient, this trial was stopped because of higher mortality in the PTBD group. The Indian study did not find a difference. And the Munzer study also did not find any significant difference. So in terms of early mortality, again, one RCT stopped early. Other RCTs, one also stopped early, but was not sure. And then an Indian study did not show a difference. Evidence was weighted down to the risk of bias given that two of the three RCTs were terminated early. So other evidence, six additional cohort studies commented on early mortality. And there was a trend toward lower mortality in the ABD group with a relative risk of 0.62 and relative risk slightly crossing one at 1.01. And the P value is slightly above five. So again, some trend toward early mortality in this patient population. Stratifying the data by the type of patients, if they were preoperative, palliative, or all comers did not make a difference in these results in terms of early mortality. What about long-term mortality? Of course, long-term mortality we expect it to be different between resectable and unresectable cases. So therefore, this was stratified based on what patient population it was. A retrospective study from 2014 found that digested survival in resectable patients with malignant hyaluronobstruction and found a significant increase in survival in ABD compared to PTBD as seen here. The quality of the evidence here was low. How about long-term survival in resectable patients? In meta-analysis, the mean difference in survival was higher in the ABD group compared to the PTBD, as you can see here. What about long-term survival in non-resectable patients? There was no difference in non-resectable patients in one RCT from India and one cohort study. What about the issue of peritoneal metastases and tract seeding, which turns out to be a very important issue? One study reported adjusted analysis on factors influencing peritoneal recurrence and in adjusted analysis. And when controlling for age, tumor stage, they found that PTBD was the only independent factor predictive on development of peritoneal recurrence with an odds ratio of 6.9 and a very significant p-value. Meta-analysis done by Wang and colleagues from 2019 based on six studies found that ABD was much less likely to be associated with seeding compared to PTBD, excuse me, 7% compared to 17% with an odds ratio of 0.27. What about success rate, the odds of technical success rates? There was one RCT and four cohort studies. And as you can see here, the odds of success was actually lower in the ERCP or ABD group. Convergent to the opposite procedure, meaning if you started, you're supposed to have an ERCP, the rates of having PTBD or vice versa. This was seen in two RCTs and three cohort studies. And as you would imagine, this was more commonly to happen in the endoscopic villary drainage group where they were more likely to be converted to percutaneous drainage compared to failed percutaneous than converting to endoscopic drainage. What about adverse events? As you would suspect, ERCP is associated with pancreatitis more commonly than percutaneous drainage. And this was seen in retrospective studies of different patients. As you can see here with the odds ratio of 3.69 and bleeding was more common in the PTBD group as you can see in the meta-analysis here. What other considerations did we think about? Cost, direct cost of ABD and PTBD may be comparable. Cost effectiveness, there was one study that specifically looked at cost effectiveness in Thailand and found that ABD was more cost effective than PTBD. Patient advocate in the panel mentioned that many patients view the external drain negatively and that it can be considered as a constant reminder of their disease and that patients don't like it. I think anecdotally we see that in our own practices. Also mentioned that external drain becomes a management challenge for patients and caregivers. And so that's an important issue for patients. There's also some negative psychological impact of seeding and local recurrence obviously on the site of the percutaneous droop because it is visible and patients view this very negatively. So to summarize, ABD is more convenient for patients who do not prefer to have external drainage. PTBD appears to be associated with higher rates of peritoneal metastases and may be associated with higher post-procedural mortality and more survival compared to endoscopic drainage. PTBD also involves having an external drain at least temporarily, which is not viewed nicely by most patients. And ABD has lower technical success rates and higher rate of conversion to PTBD, higher rates of pancreatitis and lower rates of bleeding. In terms of discussion for the panel, really the issue of peritoneal metastases may be one of the most important findings and key to our recommendation. And combined data with additional potential higher rates of post-procedural mortality. So higher rate of metastases, maybe data definitely from one RCT or higher mortality immediately post-operative within 30 days. And the potential worsening survival in PTBD in some studies, the panel decided to make a conditional recommendation against PTBD as first-line option, especially in perioperative patients. So our final recommendation, in perioperative patients with malignant hyaluronic suction, the panel suggests against routine use of PTBD as first-line therapy compared to endoscopic related drainage. Conditional recommendation, low quality of evidence. In unrespectable palliative patients that you may use ABD or PTBD, whatever is most easily accessible and available in your local hospital. Keep in mind that most patients would prefer to try ERCP first. The final decision should be again based on patient preference and discussion with the patient and the family. Disease characteristics and local expertise. So this is our graphical recommendation. Patient is potentially palliative. We suggest against sending them to percutaneous drainage as a first-line of therapy. Now, if you fail an ERCP and you cannot do it, then maybe that's a consideration, but higher rates of metastases and recurrence is very important. If patient is unrespectable, you could start with either one. Which one you should decide is based again on patient's preferences and your local expertise. Take any questions. Okay, John. Again, great. And I think out of the three, this is the one that's actually a practice changing recommendation. And I think part of it's our responsibility to disseminate this information to our interventional radiology colleagues because I doubt that people are aware even in a radiologist about the seeding and the decreased mortality. I think that's usually viewed as, well, it's a complex hypo structure. ERCP is not gonna be successful. What's the next best option? But I don't think that's the case. I think in an expert hands, it is highly successful. And as you mentioned, sometimes you have a failed ERCP. So this would be an alternative, but I would mention that with caution because there's a lot of times the first ERCP is not at a tertiary care center where people have expertise in managing chondrostrictors. And so a failed ERCP at a community hospital should not lead the patient to interventional radiology. I think they deserve at least another ERCP attempt prior to considering that, especially if the diagnosis is not established. And especially if it's unclear if that patient is a surgical candidate because potentially you may convert an operable patient to now somebody who has metastatic disease. And so I think you've got to really proceed with caution when recommending percutaneous drainage, even in one attempt of a failed ERCP, at least that's my opinion. It's important to establish the diagnosis and do right by the patient before we determine that they're not operable. And if they are, of course, then as you said, I think both options are on the table. I agree with you, I agree with you. Especially also nowadays, we have many options if you fail an ERCP with EUS guided biliary drainage, which we specifically did not address here, but certainly is becoming more and more common. And we are contemplating an ASG guideline specifically about rendezvous and hepatical jejunostomy, gastrostomy and stuff like that. So there's a lot of things that can be done if you fail the first ERCP, like you said. Certainly, especially in resectable patients, I think one of the key take home points here is think twice before you send them to IR because it's already a bad disease and it's great when they are resectable and we do not want to risk seeding the tumor into the peritoneum, if at all possible. Again, these recommendations were made with an interventional radiologist on the panel who obviously agreed with these recommendations as well. Yeah, I mean, the data is there and it's very suggestive. And I think, you know, we owe it to our patients to do right and share these. So if you want to, I mean, I think that was the last one. If you want to, so we'll summarize here the grade recommendations. Dr. Kursi, do you want to go over this or? Sure, yeah. These are on the table one again, we're trying to make these guidelines as helpful as possible. So we put our guideline recommendation in the first table. So for stent type, if you have unresectable hyaluronostruction short life expectancy, or prefers to avoid repeated intervention, consider metal stents. If the optimal drainage strategy is not established or the final diagnosis is not established, then we suggest that you put a plastic stent first. Otherwise you can use either one. In terms of drainage strategy for unresectable malignant hyaluronostruction, we suggest bilateral stents as we have seen the evidence and then there's some data to show that this is better. And then in terms of the drainage modality, they are potentially operative patients and we suggest against routine use of PTBD as first line of treatment. However, if the patient is unresectable, then that could be considered again, based on discussion with the patients. Like I mentioned before, we have a table two, which is the general concepts. And as we noticed beyond the scope of this guideline to address all clinical questions related to malignant hyaluronostruction, there's a lot more questions that we did not and could not address. So we provided some general concepts, statements on managing these patients that we think you may find very helpful. These were not based on systematic reviews and mostly represent expert opinion of this multidisciplinary panel and these specific recommendations. So I'll go through them, they're on table two. Again, review all cross-sectional imaging with an emphasis on volumetric liver assessment like Dr. Jamiri was talking about making sure you're not trying to drain an atrophic side of the liver. Discuss the case in a multidisciplinary fashion, oncology, surgery, especially if the patient may be resectable so you can make the best intervention at the time of ERCP. Limit the injection of contrast as we have been mentioning and try to limit that injection of contrast to avoid infection and introducing bacteria into undrained ducts. Avoid injection and attempted drainage of dilated ducts within an atrophic liver segment like we said. Attempt drainage of all injected. If you do inject contrast, do your best to try to drain everything that you injected because that's when people get infected. Aim to drain more than 50% of the viable non-atrophic liver volume which includes future liver remnant and resectable patients. And consider a peri-procedural antibiotic especially if drainage of contrast is believed to be incomplete. May use stent-in-stent or stent-by-stent as we mentioned. RFA and PDT, tablate lesions through SIMS can be considered in tertiary centers and in research settings at this time. So I think this table also is a very important table provides some take-home points that you should think about when you're planning these cases. Our full references are too many to list here. We have tried to list some of the studies and during the discussion but feel free to download our guideline and there you'll find all the references. That was great. The guidelines are available to all ASGE members and non-ASGE members. It is free to the public, I believe. So if you have colleagues who are not ASGE members you know, encourage them to look up the guidelines and download them and read them and hopefully they can apply them to their patients. Again, we have a few minutes left if anybody has a question. But Dr. Kumse, that was great going through the evidence and the practical aspects of this complex disease and its management. And it's evolved obviously over the years and I think patients are living longer. There's transplant options for some of these high-risk chondrocarcinoma patients as chemotherapeutic agents, there's dyscopic therapies, RFAs and there's more data coming out supportive of some of these interventions and these patients are living longer and hopefully, you know, we can help them manage this disease better, control their jaundice and drainage and infection. So with that, I don't see any other questions or chats. Thank you so much, everyone. We hope you enjoyed this. Feel free to ask us if you have any questions. We want to thank all the panel members, all SOP members, everybody who helped us. And of course, our moderator, Dr. Laith Jameel for an excellent moderation. And again, feel free to reach out to us if you have any questions. All our guidelines are available without subscription to GIE or ASGE on the ASGE website. Thank you for the ASGE for putting this together and to our staff for helping make this webinar possible. Thank you. All right, everyone. Have a good night.

ASGE Guideline

Endoscopy

Malignant Hyarlobstruction

Self-expandable metal stents

Plastic stents

Bilateral stenting

Percutaneous biliary drainage

Peritoneal metastases

Patient management