Now, let's go to Dr. Linda Lee from Brigham and Women's Hospital, who will demonstrate cholangioscopy and biliary RFA for cholangiocarcinoma. Hi guys, so I'm going to have Dr. Steve Steinway, our fellow, present our case for you guys, okay? Alrighty. So, today we're going to show a case of cholangioscopy and biliary radiofrequency ablation performed by Dr. Linda Lee, Medical Director of Endoscopy at Brigham and Women's Hospital, Associate Professor of Medicine at Harvard Medical School. So this is a 44-year-old male with a history of hyaluronic cholangiocarcinoma on chemotherapy with gemcitabine and cisplatin and immunotherapy durvalimab. He has a bismuth type 4 stricture complicated by recurrent cholangitis. His last ERCP was in August of this year, and he had balloon dilation of his left hepatic duct, and then placement of two plastic stents, an 8.5 by 15 centimeter plastic stent in the left hepatic duct, and then an 8.5 by 12 centimeter plastic stent in his right hepatic duct, as you can see on the right. So today we're going to plan for cholangioscopy first, using the SPI glass system made by Boston Scientific, and some notable features about this system are that it's a single operator system using a 10-fringe catheter with a 1.2 millimeter working channel. There's four different accessories, including the SPI bite biopsy forceps, SPI snare, SPI basket for stone extraction, and then the electrohydraulic lithotripsy probe. It has four-way steering and high definition with imaging with LED lighting. After this, we're going to perform radiofrequency ablation using the Taiwan Elra endobiliary RFA catheter. This catheter comes in four different sizes. The 11 millimeter and 18 millimeter length catheters are designed for treatment of hylar strictures, and then there's a 22 millimeter and 33 millimeter catheters, which are designed more for common bile duct strictures. We'll now head over to our case. All right, thank you guys so much for joining us here at the Brigham. I'll introduce the team in a minute, but hopefully you can see the lower right cholangiogram, where you can see stricture going up into the right main hepatic, as well as the left. And Steve, can you show us the other reference image? Steve, just, yeah, so we'll show, yeah, so you can see the bifurcation there and a bit of stricture going up into the left main hepatic, as well. I think it's on the right side, certainly the right anterior part is affected, so he's, we removed his bilateral eight and a half French plastic stents already. We swept, there was not a lot of stuff that came out, did this cholangiogram, and now we're up with a spy, and hopefully you can see the spy image. Yes, we can see it. Great. And so we're kind of at the bottom of the stricture right now, and I'm trying to advance it a little and see if I can get you guys a better view here. And are you always performing cholangioscopy before RFA? Great question. Not necessarily. I think that if you're not sure where the stricture is and whatnot, if you want a better feel for it, I think it's potentially helpful, but honestly, I don't routinely do spy before RFA. So here we go. I think there is value, I think, to doing it at the index exam to kind of help stage higher lesions, and I'm not sure, Linda and Marita, about your experience, but we have seen some cases where cholangioscopy has actually given us a different business classification than what our MR imaging suggested, sometimes upstaging, sometimes downstaging. So our surgeons actually routinely request that at the index, and that can certainly help as you plan to build your RFA as well. Yeah, I agree. I think it's- I agree with you. Yeah. And you can see the two wires there right now in spy and some narrowing happening here. I'm trying to see how far I can push my spy right now up the duct here. I think it's also helpful sometimes in really delineating which ducts you want to stent. Sometimes that can be difficult to discern on the MR or the cholangiogram itself. Agreed. So you can see, still in the common hepatic here, and not really able to go up too much further right now with the spy, I think because of the fixturing there. Do you have one wire in the duct and then spy next to it with a wire? I do, yes, and I'm losing position right now, actually, so let me try to rescue my position here if I can. Like you said, you had had an eight and a half, this Todd Baron, by the way, you had had an eight and a half French in there, and it's, of course, a 10 French scope with a blunt tip. Yep. So I think that's pretty much as far as I can go, but you can clearly see badness here. So what we're going to do now is we're going to exchange out for the RFA, which is the RFA catheter. So while we're doing that, oh, actually, let's inject a little bit. I'll show you the cholangiogram kind of real time here. Ready? Yep. So Linda, is it your routine practice now in sort of these kinds of patients to include RFA with the stent exchange, or is there a certain threshold that occurs before you start utilizing it? Cholangiogram there. Oh, yeah. Yeah. Okay. You can stop injecting. Let's do last image. Hold on that. So I'm sorry, what was the question again? Let's start exchanging. Yeah. Hey, Linda. No, I was just asking you about kind of when do you utilize RFA? Is it kind of routine now with all of your cholangiocarcinoma patients who are getting stent exchanges, or do you have certain preset criteria or select indications? That's an excellent question. And it's still evolving, right, this whole field, and I think we need more data around it. There's certainly data to suggest that RFA seems to, in combination with chemo, seems to be better, you know, when you do the RFA in terms of survival, but that's mainly in patients who have localized disease and not certainly patients with metastatic disease and then continue. And then there's also some data to suggest that, you know, RFA combined with stent, survival may be improved versus stent alone, you know, but there's obviously, you know, potential issues with that data. And so I think it's hard to say what the right thing is to do right now. I think it's reasonable in somebody who has unresectable disease to think about doing this, because overall it's a very safe procedure and might provide some benefit, but we still need more data. Now, I want to talk about the two different RFA systems that we have. Certainly, the Boston Scientific Habib has been around for a while, and that is an 8 French catheter where you can use it pretty much with any generator, right? It's generator agnostic. And then in the hilum and the ampullary region, you usually use 7 watts, and in the distal bile duct, 10 watts, and you step on the pedal for 90 seconds, so it's just time-based purely. 90 seconds on, 90 seconds off, so let the catheter tip cool before you remove it. Today, we're going to demonstrate a different RFA catheter, which is Taewoong's RFA system, which comes with its own special generator. So if we can show the generator. And while we're getting ready to show you the generator, the difference is, there's several differences, but the big difference is that the Taewoong generator monitors both temperature and impedance, and so the temperature that it's aiming for is 80 degrees. There we go. Can you guys see the VIVA generator there? Yeah, so you see temperature down there, 80, and then the time is typically 2 minutes. However, depending on what the impedance, so the impedance, there's no number because we haven't started doing anything yet, but it's measuring the amount of moisture in the tissue, and so once the tissue is dry, it's measuring the amount of moisture in the tissue, and so once the tissue has been kind of completely ablated, burned, and it's dried out, the impedance will start shooting up. Normally, it's like in the 30, 40, 50 range, certainly under 100. Then once you start seeing it shoot up, then you stop, and that could be at one minute, you know, one minute, 30 seconds, etc. And then the nice thing about this system is that when it touches metal, it automatically shuts off. So, and then in the higher ampullary region, similar to the Habib, it's 7 watts, and then more distally, it's 10 watts. And the probe is a little bit thinner. It's a 7 French silicone tip catheter as opposed to the 8 French non-silicone tip catheter for the Habib. The other big difference is that there's different sizes of the catheter. There's four different catheters that you can use, and you choose based on the length of your stricture and location of the stricture. So, there's the smallest one is 11 millimeters, and then the, I think you saw it on Steve's PowerPoint there briefly. Then the other one, the next bigger one is 18 millimeter, and those are the two that are typically used in the hylar region and ampullary region. Give me some back tension. And then there's bigger ones, 22 and 33 millimeter, which are typically used in the ectropathic bile duct. Yep. And Linda, when you treat an area, you literally do a single treatment, right? So, it looks like a single two-minute treatment, and then you just move the catheter and move to the next site. Uh, yeah. So, I think, you know, you can certainly do overlapping if you happen to choose one that's a little bit too short, you know, and there's more stricture that you didn't treat. You can pull it down a bit and do overlapping. Again, the nice thing about this system is that it will sense where there's tissue that's already been kind of dried out and burned. So, then when you see the impedance going up, then you shut it down. And then another indication for this is ingrowth into the metal stents, but I heard you say that it turns off if it touches metal. So, does that mean that this catheter can't be used for that indication? So, it can be used, and I think the thing is, so with all RFA, with both RFA probes, right, there's problems because you need good, consistent contact between the tissue and the probe, but a lot of times you have irregularity in the tissue, right? So, there may be areas where you are getting contact, but then areas where you don't. So, I know there's like a balloon RFA that's, you know, being developed that may help with that, but in the meantime, there are those issues regardless of what catheter you're using. And I think with tumor ingrowth, as you were talking about, Amrita, you can absolutely use it in that situation with this catheter because, you know, the tissue presumably is there, and then once you start burning it and get close and touch the metal, by which point hopefully that means you've done a good job of blading, then it shuts off. So, it's providing a little safety to the procedure. Yeah, exactly, providing a little safety. And since you bring up the safety issue, I mean, most of the time, you know, these are very, very safe procedures. There are, of course, you know, the main issues of cholangitis. So, we've given pre-procedure antibiotics to this patient, and you should be doing that really for all patients that you're doing cholangioscopy on, certainly, and I would argue for this kind of hyler work as well. So, that's a must. And then there's also been some reports of hemobilia, some rare bad things that can happen, or pseudoaneurysm development. And we actually had a patient that we scoped yesterday who had about, I think, nine or ten years ago had RFA and then developed a pseudoaneurysm and got coiled. So, that's, you know, certainly a very, very rare complication. I don't think that's been reported with the Taewoong RFA. And by the way, the depth of burning for the Taewoong varies depending on the size of the probe, the catheter that you use. So for the one I'm using now, which is the 11, it's about two millimeter depth. And cholecystitis is the other thing to worry about. So you really want to be careful if you think you're near the cystic duct orifice with, you know, doing RFA in that region. So here, hopefully you can see the fluoro image there. Yep. Yep. And you see the two electrodes, right? And so the burning's happening between those two electrodes there. And so we're gonna start the burning process now. And we're just looking at the impedance at the moment as the time is ticking away. And you see- Yep, go ahead. Yeah, no, I was gonna say, one of the, you know, to get back to that question about whether this is done on protocol or sort of for every patient, and I think the key thing is to, you know, kind of set from the beginning the potential plan for a cholangioscopy, I mean, for RFA, because you can repeat this, and, you know, as opposed to committing patients to uncovered metal stents, which I think traditionally has been the go-to when you have unresectable hyaluronic lesions. And I think the ability for us to perform this now really is a new paradigm. Like, really changes that management. Yeah, I would agree with you on that. Yeah, it's an excellent point, Aritha, and I totally agree with you on that. I know that the uncovered bilateral metal stents have kind of been in vogue. I have to admit, I don't like doing that a lot because these patients, thankfully, are tending to live a little bit longer with chemotherapy plus immune therapy now, right? And our patient is on immune therapy, and the other kind of theory about RFA is that it might be doing something to the immune system. So perhaps RFA combination with immune therapy will be even better than the data that we've seen with RFA and chemo. But to get back to your point, I think it's an excellent point that perhaps if we're able to do this every three months or so, you know, it will be helpful for that reason too. Yeah, I think there's some great potential collaboration with our oncologists and coming up with some strategies. Yeah. 100% agree. Yeah, and I think that's been our practice too, is that we've moved more to ablation and plastic stent and sort of doing less bilateral metal stents in these patients, because they're definitely living much longer. Yes. And sometimes those high alert metal stents can get a little hairy, particularly if you do stent and stent, but we tend to- Yeah, if you do stent and stent, yeah, you're screwed. You know, you're trying the stent and stent gets clogged and you're like, oh my gosh, you know, then they go to IR. Yeah. So it's a tough, tough- Yeah. I'm sorry, and then one other quick point on your safety point, which is for maybe those who don't do this, is that some of the early data when they use sort of the same energy levels for both extrapodic and intrapodic, there were some complications because of course, you know, you've got vessels running right next to the duct and the portal triads. And so there were some cases of bleeding. And so that's part of the reason why you're using a lower energy setting within the liver as opposed to in the extrapodic duct. So just for our audience. Exactly, exactly. So now I've moved, if you look at the fluoro, I've moved the catheter down a little bit because I didn't capture the entire length of the stricture and we're burning a little bit more distally now. And again, if you look at the Taewoong processor here, the generator, it's monitoring the time, temperature and impedance for us. It's, you know, not a difficult technique to do, certainly. You do want to avoid ablating normal tissue because then you certainly can run the risk of stricturing and scarring in that area. We already talked about trying to avoid the cystic duct orifice if possible as well. And this is the same generator that you would use for the EUS RFA? Exactly. Yep, exactly. It's the same exact generator. Yeah. So it's, you can really offer dual modality, particularly in the panc masses or lesions that might be causing ductal obstruction strictures. Yes, exactly. And there's just so much that we need to learn about this though, right? Because a lot of the data is kind of a hodgepodge of different types of cancers and they've included, you know, patients with localized disease as well as metastatic. And you might expect that this won't work so well for patients with distant metastatic disease, right? So you really want to look at the more localized patients who are not resectable perhaps for various reasons. So a lot more that we need to learn about this technology. Yeah. Nice demonstration, Dr. Lindley. Oh, sorry. We'll switch to another room and we'll come back to Brigham in a few minutes. Sounds good. Thank you guys. Thank you. Brigham, we are back with you. Oh, hi guys. So we are back here and as you can, can you see the fluoro? Yes. Yeah, so we- And I'm like, you never saw that. We have put a stent into the left side, as you can see there. Eight and a half, 12, plastic. And now we're going to stent the right side. And I think that, you know, some points about dealing with higher strictures, right? They can be very difficult to deal with and it's super important to be reviewing MRCP beforehand to kind of map out your plan of attack. Talked about antibiotic use. Talked about, I think we talked about the goal is to try to drain at least 50% of the liver. Yeah, some back tension would be great. And so that's why I think the trend is more and more to bilateral stenting to ensure that you're trying to get 50%, at least 50% of the liver drained. Did you, did you balloon? Hey, Linda, Todd Barron, did you balloon dilate after? I know you had eight and a half stent before, so you should be able to get them back in. Right, although I'm struggling a little bit right now to get the second eight and a half back in. Yeah. As you can see there. But I did not balloon dilate today because I had dilated, you know, on previous ERCPs, but that's an important point as well, because you do want to balloon dilate. And again, the reason I did it today is because I had eight and a half stent there before and thought I should be relatively easily be able to get up the next eight and a half, but struggling here a little bit. Yeah, you almost wonder if like, it's almost hitting the, at an angle where it's almost like hitting a shelf rather than going right up. Correct, correct. We didn't see it before, but did you sweep, you swept after the RFA? Oh yes, thank you. Thank you for bringing that up. We did sweep the ducts after the RFA. I think that's important to do because you want to try to sweep out, more back tension. You want to try to sweep out kind of the necrotic debris and whatnot. So we did do that. We got a little bit of debris out. It wasn't a ton of stuff, but a little bit. But it's often impressive how much necrosis, you can actually see how much necrosis you're inducing and stuff like that. Yeah, I totally agree. And sometimes you can see even a change in the cholangiogram and you can, and then I think that helps put the stents in too. Yeah, so I'm having a hard time getting this up here right now. So I might need to come out, change the position of my wire. Maybe the one that's not laying here. Yeah, the angle is a little bit, sorry, the angle of that wire is, More tension. Is a little bit interesting. Yeah, I was going to make a comment. I don't want to be a Donald Downer because, but I don't know if any of you saw there was a randomized, a large randomized trial in gut that just came out that randomized 161 patients to RFA plus stenting versus stenting alone and actually did not show a superiority of RFA and stenting alone. Canula. Canula. It's in, like I said, it was in gut. It's from Czech Republic, but it was, like I said, 161 patients, 80, almost 80 in each group. And it was that with chemo, ongoing chemo? Yeah, let me see. Let's see. I'm gonna need you to exchange now. I think as Linda was saying, I mean, there's so much unknown. Now that we have these new modalities, especially with this particular generator, where it's really looking at impedance, you could have potential to have deeper effects maybe for more mass like lesions. Yeah, I think the other problem, of course, with these kind of patients is they're so heterogeneous, right? And I didn't look to see if they, what their bismuth stage was. Stage was, those things obviously would be a big deal depending on that. Yeah, I think the thought, right, is that the lower bismuth stages may respond better to RFA compared to like a bismuth type four. There really is so much that's unknown. And I think given how, there's just much more studies that need to be done, despite that RCT that you talked about, in my opinion. Well, and the idea obviously is this is, should be technically similar to photodynamic therapy, right? When it's all set and when you look at the PDT data, there was that one study in gastro that was impressive years ago to show survival difference with PDT. Exactly. Pull the wire back a little bit. Yeah, I was just doing a quick lit search, Todd. Kind of there is a recent meta-analysis of 17 studies, 1,766 patients, including three RCTs of sort of stent patency, you know, using RFA with or without. And it appears that it increases stent patency by about 45 days in this meta-analysis. So Linda, do you, how often do you bring these folks back? And because you're using RFA, are you extending your intervals now based on your experience, or do you maintain that as before? Yeah, I mean, again, don't have a ton of experience, but bringing them back still like every three months. And kind of seeing what the cholangiogram looks like. I don't like that because it's such a short term. Can we go straighter? So yeah, so right now it's about every three months. Who knows, if it actually works, maybe we'll be able to space out the interval longer, to your point. And are you planning on upsizing to 10 French eventually on these stents? I'll switch out to the angled wire. That would be fantastic to do, although since I'm having a hard time even getting a second eight and a half in there, today is not the right time to do it. No, no, I meant- But I agree with you. I agree, yeah. We started out with seven French stents in this guy bilaterally, and then we're able to get up to eight and a half now. So yes, the hope would be 10 French bilaterally. And that's a good point that you just made. I tell the fellows on some of these complex, when you're doing multiple stenting, start out small and work your way up because even though you can get 10 French stents in on the first go, it can be, depending on the patient, some of these strictures are so fibrotic that it's hard to get, even with dilation, 10 French stents in. So it's hard to get, yeah. I really like also for these Hylar ones, sometimes I use the Jolin multi-perforated stents. I try not to use two because then you can get a lot of up-migration, especially for those difficult angulation ones. I find them to be quite useful. I mean, we definitely need, one thing that's missing, I think, is good Hylar plastic stents. Back in the day, Cook used to make the, they were called Z stents. I don't know if you guys are old enough to remember this, but they were molded literally like, almost like a Z, right? And they were designed, I think, they were called left hepatic duct stents, but they worked really well left and right. And their migration, because the problem that we have with these is they migrate both distally and proximally in these Hylar tumors, and it's very frustrating, and they seem to be really good, and they quit producing them, but I thought they were really quite good. So there's not an ideal stent for these in terms of the plastic. Yeah. Yeah, the other point I want to make about doing Hylar work is that you want to be sure that you can drain whatever duct that you put contrast into. So I think it's important to start with guide wire and see where your guide wires are going, and then gently inject some contrast. You don't want like a full blown calandrogram. You don't need that in these people. So you just want to be very mindful and thoughtful about that as well when you're doing this kind of work. Yep, absolutely. That's sort of the pre-procedure MRCP is so key, and we usually have that on one of our TV screens in the room so that we can figure where we're at. All right, is only inject what you want to drain and drain everything that you fill. Exactly. Thank you, Dr. Linda Lee. Yes. Thank you, Dr. Lee and Brigham team. That was great case and discussion. All right. Thank you, guys. Be done. See you, Linda.

cholangioscopy

biliary radiofrequency ablation

cholangiocarcinoma

SPI glass system

endobiliary RFA catheter

stent placement