Activity Transcript

James Buxbaum, MD: Hello, I'm James Buxbaum from the University of Southern California in Los Angeles, California. Welcome to this program titled, "Evidence-Based Strategies for Prevention of Post-ERCP Pancreatitis: What You Need To Know". Today we're joined by a series of experts in our discussion. First, we're going to speak with Dr Prateek Sharma, who's professor of medicine at the University of Kansas School of Medicine in Kansas City, Kansas. Welcome, Prateek.

Prateek Sharma, MD: Thanks, James. My pleasure to be here and joining you and the rest of the experts.

Dr Buxbaum: It's a great honor to have someone of your high stature here to talk about post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. First, how big of a problem do you think it is in the world of endoscopy?

Dr Sharma: Yeah, that's a great question, James. If you look at the prevalence of post-ERCP pancreatitis taking into account all the ERCPs which are done in average-risk patients, it's about 8%, and that number increases or almost doubles to about 14-15% in those, quote, high-risk patients.

Dr Buxbaum: Is the mortality and cost significant?

Dr Sharma: Yeah, definitely. The mortality associated with it is approximately 1 in 500 and the costs are staggering about $200 million annually in this country.

Dr Buxbaum: From your many years in the game, what's kind of emerged as how this happens? What's the pathophysiology of post-ERCP pancreatitis?

Dr Sharma: Yeah, so the main cause at the end, and we'll go over some risk factors as well, but what really ends up happening is poor drainage from the PD or the pancreatic duct. Again, as we know about pancreatitis in general, if you have a common bile duct stone and it blocks the ampulla it can lead to pancreatitis. Similarly, in the post-ERCP phase or during the ERCP phase, if anything that leads to this decrease in the drainage will lead to post-ERCP pancreatitis.

Dr Buxbaum: From my work in pancreatitis in general, what we've seen is, once there's a block there's a problem. And locally, then this propagates leading to the inflammatory cytokines, local injuries, systemic injury. These propagations really where nonsteroidal anti-inflammatory drugs (NSAIDs) try to work, maybe fluids at these areas, and the other strategies we'll talk about later, things like wire-guided and stents and more that are initial injury of the drainage.

Dr Sharma: Exactly, James, as you know, you're absolutely right. It starts with a local process but then becomes systemic, and we've all seen these patients who can be really, really sick from post-ERCP pancreatitis.

Dr Buxbaum: How do you think about your risk factors when you go into these cases and your team goes into these cases to look at and who may develop this or what sort cause or who's going to be particularly vulnerable?

Dr Sharma: Yeah. If you think of it this way, it's patient-related factors and then procedure-related factors. That sometimes helps you in figuring out who's at high risk for post-ERCP pancreatitis. So if you start first with patient-related factors, if a patient has a prior history of post-ERCP pancreatitis, and for some reason if you're doing the ERCP and somebody with suspected sphincter of Oddi dysfunction, or SOD, younger age, younger female gender, and then prior to start of the procedure if the patient has a normal bilirubin, those all seem to be risk factors at the patient side of things that you should be definitely keeping an eye out for.

And then during procedure, if it ends up being a difficult cannulation, if you're trying to cannulate multiple times and you're unable to do that, and then if you end up going through the precut sphincterotomy route, those are risk factors. We try not to inject the pancreatic duct (PD) if you looking for specifically common bile duct (CBD) injection. But if you end up doing that, a PD contrast injection, that's a risk factor. And then if you want to do a minor papilla sphincterotomy or a pancreatic sphincterotomy, those increase your risk for post-ERCP pancreatitis. And of course we try not to do a balloon dilation of the sphincter without a sphincterotomy, but if you end up doing that, that also tremendously increases your risk for post-ERCP pancreatitis.

Dr Buxbaum: Indeed, you mentioned the SOD patients. The Milwaukee classification is, again, patients who have 1, 2 or 3. 1 is patients who have abnormal liver tests and abnormal imaging and pain. These patients, we tend to approach them and open up the duct, think it's more of a papillary stenosis. Type 2 is when they have either abnormal liver test or abnormal imaging. Type 3, the type that gives us all a lot of dyspepsia, is when patients have pain, but they have normal liver tests and they have normal imaging. So, how do you deal with your SOD type 3s now in the wake of recent studies?

Dr Sharma: Yeah, James, you mentioned it, type 3 gives you dyspepsia, and perhaps they do have dyspepsia, which is causing their symptoms. So you have to be absolutely careful in those SOD type 3 patients. As an expert yourself in this field, you're very familiar with the EPISOD trial, which was a randomized controlled trial looking at the sham versus the sphincterotomy in these types of patients. And actually, in that trial, the sham group did actually better than the sphincterotomy group. So that is a group of patients that you definitely want to avoid ERCP and try not to do that, go other diagnostic routes, because those patients, for sure, will develop bad post-ERCP pancreatitis

Dr Buxbaum: Indeed, once upon a time ERCP was a diagnostic modality. How have you seen that evolve in terms of clinical endoscopist perspective?

Dr Sharma: Yeah, as you know, the role of diagnostic ERCP has pretty much waned off completely, and that's because of good cross-sectional imaging techniques that we have. As we all do, and these patients coming in with pancreatic or biliary symptoms, initially we start with a magnetic resonance cholangiopancreatography (MRCP) or any sort of cross-sectional imaging. So magnetic resonance imaging (MRI),  computed tomography (CT) have improved significantly, and those are the tests that we do. And then from an endoscopist perspective, you can also do an endoscopic ultrasound in the right situation, specifically if you want to use it as a diagnostic tool. So I think between those imaging types of tests, both cross-sectional as well as endoscopic ultrasound (EUS), I think we pretty much should be avoiding diagnostic ERCPs.

Dr Buxbaum: And indeed, in studies where EUS has been used before ERCP in patients who are in an indeterminate or gray category for stones, there's actually a multifold reduction in post-ERCP pancreatitis.

I think we've covered the basics of the pathophysiology of post-ERCP pancreatitis and the patients to avoid and we're going to explore more specific measures to prevent post-ERCP pancreatitis (PEP) in the subsequent chapters. Prateek, thank you for this great discussion.

Dr Sharma: Thanks very much, James. It was my pleasure to participate in this wonderful activity for a very common problem that we see clinically.

Dr Buxbaum: Please continue on to the next chapter for discussion of clinical trials in the prevention of post-ERCP pancreatitis.

Segment 2

James Buxbaum, MD: Welcome back. Now we're going to speak with Michelle Kahaleh, who's clinical director and chief of endoscopy at Rutgers' Robert Wood Johnson University Hospital in New Brunswick, New Jersey. Welcome, Michelle.

Michel Kahaleh, MD: Hi. How are you? Good to see you.

Dr Buxbaum: Very good. Thank you, thank you. We're talking about post-ERCP pancreatitis prevention, and probably the oldest and maybe truest methods to prevent post-ERCP pancreatitis is pancreatic stents. Just want to get your feeling of the use of this tool to prevent pancreatitis.

Dr Kahaleh: Yeah, I think it's a very valid question considering all the studies that are ongoing really to prevention of post-ERCP pancreatitis. And as you know, you published a very nice meta-analysis in 2023. It's difficult not to mention it. I thought you did a fantastic job capturing the biggest series that are looking into the problem, all comers indication of prevention of post-ERC pancreatitis with pancreatic stenting. And pretty much the global feeling that you get from that study is post-ERC pancreatitis seem to be prevented by pancreatic stenting.

And this is a kind of message that has been shared in the community of advanced endoscopist, that anytime you're dealing with a procedure where there is a risk of post-ERCP pancreatitis, you're going to be placing a pancreatic stent in. And I think everybody agrees with this, the effect is confirmed for all comers ERCP, but specifically when you're trying to limit the chance of moderate or severe post-ERCP pancreatitis. Not only it seemed to be functioning on the global incidences of pancreatitis, but it seemed to definitely provide a benefit to prevent severe post-ERCP pancreatitis.

Dr Buxbaum: Indeed, as part of the meta-analysis, really the team bid as part of the American Society for Gastrointestinal Endoscopy (ASGE) guideline, we did look at all the extant literature and overall the odds ratio was 0.35 for prevention with pancreatic stent. However, as you allude to, it was more pronounced for moderate and severe post-ERCP pancreatitis, with odds ratio being 0.2. So it was actually the only preventative measure that prevented the actual severe type of pancreatitis and moderately severe and severe type.

But there is some equipoise which led to the SVI trial, which I think we're going to talk about a little later, that there may be some issues with pancreatic stents, in terms of technical skill of placement or complications that can happen due to the stents. How do you get around this or approach it or work with this with your trainees and your colleagues?

Dr Kahaleh: Yeah, I think it's very important when you talk to your referring doctors to explain to them that placing the pancreatic stent is not something easy. It's something that you need specific training, you need to have the appropriate stent, the appropriate wires, the right assistant. So it's not something that you do on a regular basis. So you have to be appropriate to training. And we tell them if you are not comfortable placing a pancreatic stent, you should try to avoid placing a pancreatic stent and you should consider other alternatives. Or maybe if the case seem to be too challenging, don't even start the ERCP. Refer the ERCP before even attempting a very challenging procedure.

Dr Buxbaum: This came up a bit with the guidelines and the wording. I have to take a look at it again, but part of it's if you already do have good access then to proceed with the stent. But if it's maybe not access, it's a little bit more vague. Another thing that's come up in the last 10 years or so is a concept of the classical approach of doing contrast guide approaches to the duct versus wire guide approaches to the duct. And just get your feeling on this too as an expert endoscopist.

Dr Kahaleh: This is actually a great topic because I was trained with cannulining with the cannula, and injecting contrasts. And this is something that we wouldn't consider anymore. There's a lot of study that have demonstrated that actually a wire gathered cannulation reduced post-ERCP pancreatitis. And there was recently another meta-analysis that was actually published about that topic, showing the risk ratio of 0.51 if you actually use this technique. Which means you should always start with a sphincterotome priered with a wire, nowadays. The old concept of trying with the cannuline, injecting and re-injecting until you get contrast and then cannulining, this is something we don't do anymore. The study have clearly demonstrated that this should be abandoned and you should focus your training and training the next generation with a wire gathered cannulation approach.

Dr Buxbaum: And fully agree. One caveat though, we did look at this, did sort of a post-talk stratification on that meta-analysis by Francis Save, which is in the Cochran database now. But it did appear there is a little bit of equipoise of whether you put the wire first and then your tome or whether the tome first and the wire. It seems like if the wire goes first, kind of feeding the way, that maybe some of that benefit is lost. So I think the argument is possibly there's more fistulizing if you're a little too aggressive with the wire. I fully agree to avoid that, the heavy inject of contrast, but the exact approach I think there's still a little bit of play on what the very best approach is.

Dr Kahaleh: Which is true. It is true. I think it's very difficult to define exactly what should be the distance between the sphincterotome and the cannula, and the ampulla. When you cannulate it with the guide wire. I think what most people recommend is once you see the tip of the wire engaging into the appropriate duct, to then follow gently with the sphincterotome. Because that is two things that's going to allow you then to perform the procedure safely.

First of all, you will be already engaged with the sphincterotome and so it'll give you more leverage by manipulate your wire safely. Number two, you won't be losing access, because the wire is still very floppy. So it's very easy to lose access if you try to engage the wire completely before advancing the tool. So this is obviously something that comes with training and performing a large amount of ERCP, but the concept can be taught gently to your advanced instructors.

Dr Buxbaum: I guess the main concept is avoid all those contrast injections so pancreatic duct can inadvertently and prevent pancreatitis. So turning a little bit into the more pharmacologic realm, there's been a lot of buzz about NSAIDs since Joe Monger's landmark trial in the New England Journal and it's where to use it, it's been a little bit of a debate. Where do you use rectal NSAIDs in your practice these days?

Dr Kahaleh: Anytime we have a version ampulla or a difficult ERCP, we tend to offer NSAIDs. I think that the data seem to support this approach. There's no downside to it, so why not offer it? We don't offer it for 10 revision or anything like that. But otherwise we considered that any version of Pula or complex CRCP should benefit from NSAID.

Dr Buxbaum: So obviously looked at that for the guidelines and we actually looked at all the unselected papers, so unselected patients, and then the high risk. And there was a twofold or more reduction really in both groups when we harmonized all the data. So definitely supports your practice. But as you note that a lot of the studies that were unselected patients were patients with a native papilla. And most of them didn't include stent changes. So that area is still a little bit gray, but overall it looks like the data does support using them in most ERCPs or certainly when it's a first ERCP. Would you say that typically if it is the first case, say a de novo stone or de novo bio leak or things like that, you will in incorporate NSAIDs into your procedure?

Dr Kahaleh: Yes, we have made it a standard in our institution.

Dr Buxbaum: Yeah, it's interesting, like 10, 15 years ago, this wasn't a practice but it's another thing it's really emerged. Now topic close to my heart is the aggressive hydration after your CP. Some people are using it with a lot of the cases. There's some debate. So we did look at this with the guideline and there was a reduction in PEP, but Nikhil Thrugangam and the group at Penn did cost-effective analysis, which showed that it may not be cost-effective for all comers but does appear to be more cost-effective for those that are high risk. What's your feeling on the hydration, the fluids flowing through the units these days?

Dr Kahaleh: I mean the cost-effective analysis was very interesting. I read it with a great interest. Actually, I gave it to our advanced instructors. They present a journal club and then in that study actually they were talking about cost effectiveness of the $139,000 to invest to prevent post-ERCP pancreatitis, any consequences in unselected patients. That number dropped down to $28,000. So the problem of this is they were looking only at primary intervention, which is basically getting admitted or not.

You have to be very careful when you do this because there's always secondary and tertiary intervention. Some of those people, when they get admitted specifically the high risk one, they can need a feeding tube, they may need a gastrostomy, they may need eventually to go to surgery. So you have to factor all this in. So I would say $139,000 to prevent a patient to eventually getting a feeding tube or a cystogastrostomy is actually acceptable. Definitely $28,000 is highly acceptable. So you have to be very, very careful when you read those paper. I think they are great paper but you always have to think about secondary and tertiary intervention.

Dr Buxbaum: Indeed. The other thing with the cost effectiveness modeling is they had to assume that every patient who got fluids was admitted 24 hours. When in reality this is often done a little bit more quickly in an outpatient setting, which will probably bring down the cost. But talking with Nikhil and the authors, it's very hard to model it for just a few hours. So they had to kind of use that with the Medicare codes and things with the way that was done.

So the big paper came from Europe. The FLUYT study, it came from the Dutch pancreatitis group and this was a big study looking at basically the combination of NSAIDs with fluids versus NSAIDs alone. And interestingly they didn't find, and this was keeping people 24 hours, they didn't find it a highly significant reduction with the combination therapy. Although maybe there's a trend towards less moderate and severe disease with the fluids. So this led to some equipoise about the use of fluids. Very interesting study. What's your thoughts on this one Michelle?

Dr Kahaleh: I think it's a very interesting study, but there's two things to consider. Number one, what will be the drawback of not giving fluids? I mean unless you have somebody who is cardiac challenge, congestive heart failure (CHF) or something like this, I just don't see the downside of giving fluid. There's no real adverse event except if you cannot tolerate high volume overload.

The other thing is you always have to look at the power of a study. You have to question was this study powered enough? Because they included several type of patient in that study. There was not uniform kind of patients. Anytime you do a study about post-ERCP pancreatitis, you got to decide what am I talking about? Am I considering people that got ampullectomy? Am I considering people that had the precut sphincterotomy? Am I considering people that have pancreas diseases? And I'm considering people that have difficult cannulation due to whatever reason.

So when you have such a wide variety of patients, you have to always question the validity of the power analysis that you've done before starting the study. So that is my biggest concern always. So I would say I would need a study with way much more patient if we want to look at every single patient in the go in ERCP to believe that study.

Dr Buxbaum: I thought it was a brilliant study. Mike Chris was similar. It was powered basically to look at the reduction to be exactly equivalent to just doing NSAIDs versus a placebo. And I do think since NSAIDs are effective, you probably have to have a bigger sample size now that you're doing a combination therapy. Kind of like with blood pressure trials, when you're adding second and third agents, you have to go with a bigger group to show the smaller incremental change. So I tend to agree with you about that.

The last one, which is probably coming up pretty soon, is the SVI study. I was honored to be part of this and a lot of folks were around the United States, so this was looking at the administration of NSAIDs alone, or NSAIDs plus pancreatic stents. I think the results will probably be out fairly soon on this because the study's now completed with more than 1900 patients enrolled and enrollment's stopped. What's your sort of overall thought on the giant SVI study and where it may take things?

Dr Kahaleh: I mean it will be very interesting to see the result. Everybody is extremely interested to see what's going to come out of it, obviously. Because he's Indomethacin, the miracle drug that's going to allow us to skip placing pancreatic stent. I can tell you that everybody in the community is looking forward to that result. They would like to see that outcome from the result. I'm still waiting. I want to make sure that they're not supporting each other. I think they work together very well. Each one of them has different mechanisms. I don't think you can replace one by the other, but I think we need to look at the result because this may change completely our guidelines.

Dr Buxbaum: No, it's going to be big, but I agree that I agree that likely the way, looking at other parts of medicine, whether it's blood pressure or HIV control or sterile technique management in the operating room. Generally combination therapies kind of employ the different mechanisms of how things happen and tend to be the strongest. I suspect there's going to be a role for NSAIDs and stents in the future as well, for the prevention of EP.

Well, I think that covers a lot of the data and so Michelle, I wanted to thank you for this great discussion and please continue on to the next chapter for the discussion on the recent guidelines for prevention of post-ERCP pancreatitis.

Dr Kahaleh: Thank you, Jim. It was great to discuss with you. Any time.

Dr Buxbaum: Thank you, it's an honor.

Segment 3

James Buxbaum, MD: Welcome back to the program. Next we're going to speak with Dalbir Sandhu, who's assistant professor of medicine at Creighton University in Phoenix, Arizona. In this segment, we're going to review the fundamentals of the new ASGE guideline. Dalbir, welcome.

Dalbir S. Sandhu, MD: Thank you, James. I'm really excited to be here. Let me dive right in. I'm actually going to be asking you a few questions because I recently read your guidelines and I think these are really timely, very important, and extremely well written guidelines that came out by ASGE, American Society of Gastrointestinal Endoscopy, in 2023 to prevent post-ERCP pancreatitis.

Dr Buxbaum: Really the work of the whole ASGE Standard Practice Committee.

Dr Sandhu: Yeah. So the first question, which I actually wanted to ask you was, our goal is to prevent post-ERCP pancreatitis, which is one of the most common complication after ERCP. So what measures can we apply in the pre intra procedure and post procedures? So I read in the pre procedure you can give rectal NSAIDs. What did you find? Was it beneficial in all patients or just high-risk patients?

Dr Buxbaum: Well, the way we framed the guideline with kind of pre interim and post measures really, Bashar Qumseya of University of Florida who is a chair of the committee on campus, is this good framework for it. The most important thing we looked at initially was NSAIDs for high-risk patients. And so we did a systematic review of that and we found that actually not just for high risk, but actually for unselected studies, that there was a benefit of NSAID use. And so in the guideline we recommend rectal NSAIDs both for unselected patients, so for all comers, and there's a moderate quality of evidence for that and also for high-risk patients, there was also, we recommended it, there was a moderate quality of evidence. So both the groups, we recommend this approach.

Dr Sandhu: Got it. And in the rectal NSAID group, it's mainly indomethacin and diclofenac.

Dr Buxbaum: That's right. So both those agents are, there's data support both of them. Of course, as part of the other concept that goes on with the guideline that we do mention that these aren't necessarily recommended if someone has recent peptic ulcer disease or renal insufficiency. These are contraindications, the agents. Indomethacin 100 [mg] or diclofenac tend to be the ones that have been used. And typically, they're administered 30 minutes before or up to during the procedure in most of the studies. So that those are kind of technical pointers of use.

Dr Sandhu: Yeah. So for the intra procedure, I read wire-guided cannulation, which is very commonly recommended these days. And even that in wire-guided cannulation, how you engage these sphincterotome, what do you think how that plays a role intra procedurally to prevent post-ERCP pancreatitis?

Dr Buxbaum: This is a conditional recommendation, exactly how to do this isn't completely clear, but there is good evidence that a wire-guided approach, rather than injecting contrast, should be used to decide what duct you're in. It seems to favor use first of passing the tome and then following with a wire. It's important to avoid forceful or repeated wire advancements because this can cause fistulisations. So those are considerations. As more studies come out, I think we'll understand more of the real nitty-gritty of this. But in general, the endoscopist should use wire-guided versus contrast. And there's some evidence also support that endoscopist should control the wire, at least have a very close relationship with your assistant who's running the wire that this isn't the case.

Dr Sandhu: And the other thing intra procedurally of course, is placing pancreatic duct stent because traditionally that has been the most effective way to prevent post-ERCP pancreatitis. Can you elaborate a little bit further on that? What size of the pancreatic duct stent? Should it be put in every patient or just high-risk patients versus unselected patients?

Dr Buxbaum: So the data is primarily in high-risk patients. And what we've found is that in those who've had repeated access, especially during cannulation attempts, there's strong evidence to place a pancreatic stent. And in this group, we actually gave a full review of the work strong recommendation for this. For patients who are high risk overall and who perhaps maybe you haven't yet gotten the pancreatic duct, it's a little bit grayer where you should try to go after that duct just to stem it. And I think there's still an ongoing debate.

We did recommend it for high-risk patients, given the data does support this, but it is a conditional recommendation given that the real nuance of this still needs to be worked out. Overall, given the nature of the studies, we recommend three French to five French stents ranging in size from three to seven centimeters. Typically, it's purely for prophylaxis. We recommend that there be a KB or basic imaging to assess for migration and if it's still there, needs to be removed. And typically if you can't pass the genu, it's difficult. We recommend just placing a short stent rather than trying to negotiate a sharp turn and risk any kind of further injury from that.

Dr Sandhu: Do you think there are any shortcomings to putting that pancreatic duct sent? One of the things that you mentioned is, let's say you are not able to get into the pancreatic duct or after you're done with the ERCP, should we actually go after that pancreatic duct?

Dr Buxbaum: That's a good question. That's a tough question. That's why there's quite a bit of language in the guideline. Initially, you're talking about the stronger recommendation. If you already have access and you repeatedly accessed it there, it's quite a strong recommendation just to go ahead and place a stent over your wire that's already in the duct, whether you're fishing for the duct, that's where it gets a little grayer. That's why it's a conditional recommendation for the second part, if you're talking about real high-risk patients and things where you don't yet have the access. It's not entirely clear yet.

Dr Sandhu: Got it. Got it. So those are I think the main intra procedure things that can be done to prevent post-ERCP pancreatitis. And finally, post procedure, what things we can do to prevent or to decrease the rates of post-ERCP pancreatitis?

Dr Buxbaum: So it is part of the guidelines that there is evidence of support, a peri procedure and post procedure hydration. And so we do recommend this. It's conditional given that the cost-effectiveness is a little bit grayer depending on the risk level of the patient following your CP. We do say to avoid this, in those that are at risk for volume overload, for example, congestive heart failure or patients who have renal insufficiency. Most of the data supports lactate Ringer typically at a rate of bolus of 20 cc per kilogram followed by three milliliters per kilogram per hour. And this may be more feasible for inpatients who are already present. That's again the cost-effectiveness question, probably not cost-effective to keep them just for this. But in many cases, these are done in inpatients since they're made up of the native papillas for the most part.

Dr Sandhu: And I think there was a trial, FLUYT trial, where they looked at aggressive fluid plus rectal indomethacin. Do you have any comments on that?

Dr Buxbaum: So that showed there wasn't necessarily a benefit in combined therapy. But again, that was not necessarily powered to look at combination therapy. So I think the jury's still out a little bit on that. For the guideline, we still do recommend the fluid and we recommend NSAID, but which you allude to which is interesting because for example, the ESG guidelines, they tend to recommend things done more in parallel, whereas they'll say to do this measure and you can't, but to do this measure, do say NSAID, you can't, the patient has say, an NSAID allergy or peptic disease and do PD stent, if they do, this impossible then do fluid. ASGE is a little more agnostic of this, just acknowledging there isn't a lot of studies with combined therapy yet and really just analyze end result therapies, which we've gone over here briefly.

Dr Sandhu: So yeah, I think the European Society of Gastrointestinal Endoscopy, they also came out with their guidelines sometime back and they included giving octreotide or nitroglycerin or glyceryl trinitrate. They also looked at other medications like gabexate, some antibiotics, heparin, but I don't think any of those have shown a strong results in preventing post-ERCP pancreatitis.

Dr Buxbaum: Yes. ASGE really wanted to focus on where there was high level randomized evidence. And so these sort of three or four areas where there have been a number of trials over time and in multinational centers, so there is a little more confidence one way or another, whether it does or doesn't work for those, the focus of these. The other therapies are interesting, but I think they have a ways to go with data, whether they're up or down.

Dr Sandhu: Yeah, no, I think these guidelines are really, really important because in our database study, we also found that only one third of patients were given any post-ERCP prophylaxis to prevent that pancreatitis, especially the rectal indomethacin is severely . There were some other survey studies, also one from Austria, they found only 7% of physicians who were using any form of either rectal NSAID or pancreatic duct stent. So these are, as I said, really important and I think it is important for our clinicians also to use more to prevent one of the commonest complication of post-ERCP pancreatitis.

Dr Buxbaum: I definitely hope that's sort of the intent of the guideline. They raise a recognition of NSAIDs and their measures and other strategies to prevent this adverse event. And I think programs like this Medscape program as well will help to raise the awareness of practitioners and patients as well. Dalbir, thank you for this terrific discussion of the guidelines.

Dr Sandhu: Thanks James. It was really exciting to talk to you about these guidelines which are timely, important. And also it's really important that our clinicians use more and more of these measures to prevent this important, this, I would say deadly complication, post-ERCP pancreatitis.

Dr Buxbaum: So for the audience, please continue on to the next chapter. For discussion, "Applying the Guidelines to Routine Clinical Practice".

Segment 4

James Buxbaum, MD: Welcome back. Next, we're going to speak with Jonathan Cohen, who is a clinical professor of medicine at the NYU Grossman School of Medicine in New York City. Welcome, Jonathan.

Jonathan Cohen, MD: James, thanks very much.

Dr Buxbaum: So far in this program, we've talked about the risk factors and pathophysiology of post-ERCP pancreatitis. We reviewed the evidence or strategies to prevent post-ERCP pancreatitis and discussed the recommended guidelines for its prevention.

Now, we want to talk a little bit more about how we can apply these guidelines in real-life clinical practice. Dr Cohen, as a high-volume endoscopist, where do the guidelines and practice differ in what you see?

Dr Cohen: Well, the guidelines I view as a tool to help me and my colleagues do a better job performing safe and high-quality endoscopy. It doesn't mean that every single case actually must follow exactly according to what is stated, but instead, it becomes the default where it makes it easier to do what is evidence-based and the right kind of practice. For example, if someone is a very low-risk patient, sometimes we might opt not to use because in the randomized studies, even though non-selected patients show a benefit, the subset of very low-risk patients themselves haven't been independently studied. So there might be-

Dr Buxbaum: Absolutely.

Dr Cohen: ... for instance. But it's much easier to have to come up with a reason why not to use for a particular case than to have to always remember to do it. So it makes it easier to be good.

Dr Buxbaum: Absolutely. Absolutely. How are you talking about your patients about post-ERCP pancreatitis and also about how to prevent post-ERCP pancreatitis?

Dr Cohen: Well, that's an important part of the conversation that is usually in describing the procedure and part of the consent process, which is ideally done not right before you're taking the person into the room for the procedure, especially if it's an elective patient. That's something that happens preferably well before.

I think patients are expecting to know that there are some adverse events, and I think it's important to be just very upfront about it. But it's just not just talking about that. They want to know after the procedure, what happens? "When do I get to go home? How long do I have to stay?" You have to tell them they might be staying longer, that you observe them for a certain period of time afterwards to see if anything untoward occurs in terms of abdominal pain and the possibility of post-ERCP pancreatitis, what that might be, what they might experience and also about the degrees of severity. Because the fact that even if you give them a percentage of how often that might occur that it's happening say, for example, five to 10%, if you quote that, then you have to say, "However, most of those patients will go home in a few days, but it can be quite severe." So that's the kind of conversation that you have to flesh that out.

In addition, I think it's a great opportunity, at the same time, to go over the steps that you're taking to minimize that risk, and I think that's a great opportunity to make them understand that you're... So you're being straightforward about it, but you're telling them all the things that you're going to do to help prevent that from happening.

Dr Buxbaum: Is there kind of special things or different ways you're managing patients who are particularly high risk for post-ERCP pancreatitis?

Dr Cohen: Yeah, there sure are. I think the number one, two, and three thing is not to do the procedure in someone that you perceive is high risk and where there's not a good indication to do it.

I think also, I think the first thing is you have to ascertain if there's a high risk. So spending the time when one is deciding about doing an ERCP, yes, it's very important to really focus on the indication, but I think really doing a good assessment. Do they need cardiology clearance? What is their risk for cardiovascular complications? For pre-ERCP pancreatitis in particular, you have to ask if they've had ERCP before and have they had a problem before with pancreatitis. If you don't ask, then you don't know in advance sometimes if they are high risk.

In addition, there are several things during the procedure, I would say. If someone is at high risk and they are contraindicated to get indomethacin, it's really important to get them there a little early so that you can really load them up with the appropriate amount of fluid as per the guidelines and as per one of the things that you can do preventatively. So that's important to do.

I think during the procedure one of the things is if something isn't working, you got to move on quickly. I think that the whole quote about doing the same thing over and over again and expecting a different result is lunacy. I think that one needs to go and if you're not getting in easily, rather than keep trying that papilla that way, you need to try another early on, especially in someone who's a high risk. In particular, if I get a wire in the pancreatic duct, I do not take that wire out and try again to get into the bile duct. I say I'm there. I am now going to do a dual wire technique. I'll go right to it, which quite effective. I will do wire-guided cannulations now pretty much with all my ERCPs initially because of the data showing that it's decreased the risk of pancreatitis, as was shown earlier in this program.

I also will say that even though it is uncertain yet whether or not a stent plus indomethacin is necessary on top of indomethacin alone, which I have given almost all the time before the procedure, if I'm already in the pancreatic duct with a wire, I'll leave it in and it's quite easy to place a stent afterwards.

So I think that those are some of the specific things which I will do in my approach to a higher-risk patient. Some of those things I might do with a general patient, but I'm a little bit more stringent about that with someone who is at high risk.

Dr Buxbaum: Indeed. How is the care team involved in implementing these strategies to mitigate your risk of post-ERCP pancreatitis?

Dr Cohen: Well, as you know, ERCP endoscopy in general is a team sport, and it's really important. If someone is going to be getting hydration before the procedure, they have to be communicating with the team and the room where they're coming, if it's a post-anesthesia care unit (PACU) or wherever it is beforehand, communicating with the nurses what you want, that you want that IV in, you want the IV started in advance and explain the rationale.

The other thing is just in general, during the procedure, communication is key in ERCP, communicating with the anesthesiologist about what's going on, and perhaps if you want to make sure the hydration is going on at a fast rate. They have to know what your goals are with hydration, if that's one of the ways you're using to reduce the pancreatitis rate.

I think with a wire work that you're doing with nurses often, knowing what you're doing, if you're in the pancreas or the wire, you don't want them pulling the wire out because they think we're going in the bile duct. The two-way communication that we do in our general ERCP good practices is key as you're trying to also efficiently do the ERCP without banging up the papilla. So you really are all talking and making sure the equipment is right, making sure that if you might need a pancreatic duct stent, that the soft small length and small diameter pancreatic duct stents without an internal flange are present. They don't have to go looking for them. They're there in case you need them. So that's sort of the way I view it as a team communication, very important.

Dr Buxbaum: I love how you've really kind of set up ways to quickly implement the best practices to prevent post-ERCP pancreatitis, having the order set with your rectal indomethacin or rectal diclofenac, an expectation that the stents are ready when you're doing wire-guided cannulation, which you adopt in your practice, and then alerting your team about the importance of fluids and things of that nature. So it's a great example of how to carry these things into clinical practice.

Any kind of final words?

Dr Cohen: Well, this is such an important topic. I mean, we do things which in ERCP, we can make a tremendous difference in our patients' lives. We're dealing with sometimes very critical issues, and it's imperative that we take all the steps to make sure our patients are safe, then we can keep doing these very effective techniques and minimizing the adverse event. In particular, post-ERCP pancreatitis is perhaps one of the most important outcomes for high-quality ERCP and, fortunately, we have some good practical things we can do in practice to do so.

Dr Buxbaum: Terrific. Well, Jonathan, thank you for this great discussion and coming with us today.

Dr Cohen: My pleasure.

Dr Buxbaum: Thank you to the audience for participating in this activity. Please continue on to answer the questions that follow and complete the evaluation.

This transcript has not been copyedited.