Our first session will be upper GI, starting at the source, and our first speaker will be Dr. Nicholas Shaheen, who is the Chief of Gastroenterology and Professor of Medicine at the University of North Carolina in Chapel Hill. He'll be presenting a talk titled, All Barrets Should Be Ablated. My name is Nick Shaheen. I'm from the University of North Carolina. We're starting this session off with a point-counterpoint, and I'm going to be taking the perspective that all barrets should be ablated. Let God sort them out. Here are my disclosures. Let's start with some ground rules. It's no fair dredging up the debater's previous writings on these topics, right? Because as many of you know, I've been involved in the development of guidelines for barrets for ACG for the last couple of times we've done this, and clearly those guidelines don't support ablating all barrets. I would point out to you that the standard that we use for evidence and guidelines is different than the standards that we would use in everyday practice, and oftentimes when we're having just a guess, what's the best treatment for barrets? So it's not surprising that many things that turn out to be useful in guidelines don't actually show up in the guidelines initially until adequate evidence has been collected to demonstrate that. I'd also point out to you that I often drink alcohol when I'm writing, so it's not surprising that a lot of what I've written turns out to be wrong. Don't get too upset about that. No fair invoking the need for more data. People at these podiums love to say, well, we need more data before we make these decisions. People in this room may have to make this decision on Monday. You're not going to do a randomized control trial over the weekend. You have to make your decision with the data that are available. So what are the best data available? Let's take a look at them now. And finally, with respect to Satchin, there's no fair invoking our close personal relationship in an effort to plead for mercy if his argument crumbles like the ramshackle house of cards that it is. So those are just some ground rules that I'd like to propose. Now let's talk about this decision. Should you or should you not ablate everybody with Barrett's? Well, it's like any other clinical decision. You have to weigh the risks and the benefits. And here are the risks. Peri-procedural complication, I'll show you what that really means. Incomplete ablation, which certainly can happen, although we're quite good at it now. Buried cancer, which turns out to be something we worried about a lot, but turns out to be on the case report level in terms of how often it happens. And obviously, the cost. Are you going to save the insurance company's money? What are the benefits? Well, the big one, in all caps, is decreased cancer risk. Can we decrease the cancer risk of these patients? These patients are all nervous about getting cancer, and that cancer risk is real. Obviously there's cost on that side, too, because there's cost to surveillance endoscopy. You're going to hear about, well, gosh, we shouldn't ablate these patients. We should do surveillance endoscopy instead. Let's talk about the evidence behind surveillance endoscopy. If you choose not to decide, you still have made a choice, and the choice you're making is surveillance endoscopy. So you have to defend surveillance endoscopy if that's what you're going to choose. And finally, I would point out to you that there's a substantial psychological benefit to having a precancerous condition ablated. So what are you likely to hear from Sacha? Sacha's going to tell you a few things. He's going to say, we don't know if it works. The risks of progression in nondisplastic barrett's are low. It's going to hurt people. We're going to hurt a lot of people if we do all this ablation. It's expensive, and we have chances to intervene later. If we just leave them go and they progress to low grade or high grade, we can ablate them then. So let's talk about these points. Does ablating nondisplastic barrett's esophagus work? Well, no one can contest that it leads to a high rate of complete eradication of intestinal menopausia. If we ablate you for nondisplastic barrett's in a modern lab, there's greater than a 90% chance that we're going to get you to complete eradication and get rid of your barrett's. How do I go back on this? But does it stop the development of cancer? That's the real question. And I would say that yes, the available data suggests that it does. Let me show you these data. So the best data on this are probably from the USRFA registry. And to remind you if you don't remember what this looked like, this is 5,500 patients, 80% of whom were ablated in community practices. So this was an enormous effort, gathered up to five years of data on these patients, at least three years on the average. And what it showed is a markedly decreased rate of cancer in the nondisplastic barrett's group when compared to historical controls. Now I grant you, this was not a randomized controlled trial. And it's not a head-to-head comparison. But let me show you some of the data here. As best we can tell, the data from this registry, which amassed thousands of patient years of follow-up, was about 0.5 per 1,000 patient years was the reported rate of cancer. Notice that with the lowest reported rates of cancer in patients with nondisplastic barrett's who are just followed natural history data, lowest reported is about 1.5. The meta-analytic data suggests about 0.25 to 0.3. So you're getting a six-fold reduction, somewhere between a 50% to 90% decrease in cancer risk when compared to historical data. And by the way, comparing the 95% confidence interval of these data to these point estimates was all highly statistically significant. So I would say that yes, there are good data to suggest that there is a strong protective effect in nondisplastic barrett's. Is the risk too low to justify treatment? Well, to put this in some context, I want to show you some data. We spend most of our day actually trying to prevent colon cancer, right? That's what most of the people in this room do. And colon cancer occurs in about one out of every thousand screen age eligible people in any given year. And many of you know these data, these are the data that just came out two weeks ago that we've all been apologizing for, the Nordic data. You can see here there are two, and these are pretty good data, showing that about at 10 years out, about 1% of folks in each of those two arms were getting colon cancer. So that's about 1% in 10 years risk. Now EAC, as I just told you, occurs in about three out of every thousand patients with nondisplastic barrett's annually, or about 3% at 10 years. These are different studies, but if you would superimpose the risk of esophageal adenocarcinoma on this data, that's what it looks like. So you're spending all your time trying to lower the risk in these two lines, and you're telling me that this risk of a more lethal cancer, a more lethal cancer, if you get esophageal adenocarcinoma, 80% chance you die of it. That it's not worth making this effort. You're telling me this? How about safety? My God, we must kill a bunch of these patients. If we're going to ablate all these nondisplastic patients, we're going to have all sorts of complications. Well, not so. Same study, 5,500 patients, 15,000 treatments. What happened to these patients? 283 complications, about a little less than 2% per treatment, almost all strictures. Of the 283, 233 were strictures. You are certainly going to dilate some of these patients. Bleeding and a smattering, hospitalization in a few, mostly for pain control, two perforations out of the 15,000 treatments, i.e. getting pretty close to diagnostic upper endoscopy, zero deaths. This is a safe procedure. And these are community data. These aren't ivory tower data. This is what happens in the real world. I find it ironic that the people that oppose ablation of nondisplastic Barrett's on the grounds of lack of data propose performing endoscopic surveillance. Well, we know that this is an intervention for which there's almost no supporting data and plentiful data questioning its efficacy. So you say, well, gosh, let's survey them instead and think about that for a second. Imagine the not so great alternative, a hypothetical situation, 80% of people who want to come for surveillance do actually come. In those patients, 80% have appropriate biopsy protocols. In those patients, 80% have correct histological diagnosis made. In those patients, 80% have the correct intervention based on histology. You can see where I'm headed with this. 0.8 times 0.8 times 0.8 times 0.8, a single administration of endoscopic surveillance endoscopy has the likelihood of being done correctly 41% of the time. And by the way, everything on that slide is an overestimate. When we look in the real literature about this, all the numbers aren't that good. So it is the standard of care in America to do this wrong. And this is what we're saying we should do instead of ablating the patients. Can we afford it? Well, there's a lot of question about that. And some data do suggest that it may not be as cost effective as surveillance. But these analyses are based on poorly understood variables. They generally show an increased life expectancy in people who do get ablated. So it actually is more effective. The question is, what's the cost? And we use this threshold of $100,000 to buy a life year. Some are close to $100,000, but most go over a bit. Lots of stuff we do actually is over $100,000 in cost. I'll point out an interesting analysis that John Inadomi did a few years ago that actually showed that the most cost effective strategy for nondisplastic patients was to ablate them all and not survey any of them after. And the reason for that is that you take advantage of the efficacy of ablation and you get rid of all the cost and poor performance that I just showed you of endoscopic surveillance. And if you look at these data, if you're not used to looking at one of these cost effectiveness charts, this here along the x-axis is quality adjusted life years. This here is cost. So you would ideally want something to be very low cost and very long in quality adjusted life years. And you can see this star represents ablation without surveillance. It is both the longest life expectancy and the lowest cost. So it dominates the other strategies. Finally, let's talk about chances to intervene later. Well, Satchin's own work shows us well that a substantial portion of patients with Barrett's are given the wrong follow-up or no follow-up at all. And all of us have had experience with loss to follow-up with serial endoscopy. It's as much as 30% in some reports. So if you say, let's bring them back, well, just understand that there's many that won't come back. And by the way, the follow-up exams have the same flaws that the index exam had. So what are the questions we should be asking to nail down this argument instead of saying, well, let's not ablate them? Well, what we should be asking is, how can we make ablation cheaper so we can offer it to everybody with Barrett's? Can we make ablation even safer than the already excellent safety data that we have? Can we make ablation more effective such that a patient with nondysplastic Barrett's who does achieve complete eradication won't need endoscopic surveillance? And what evidence do we need to substantiate the utility of endoscopic eradication therapy so we could do all these patients? Instead of saying, then, think about this from the patient's perspective. You have a precancerous condition. I'll see you in five years. This is not what your patients want to hear, and you've heard an earful from your patients because you know it's not what they want to hear, especially if they've been on the internet and say, I know there's something out there that has a 90% chance of curing me. So in summary, I would tell you that ablation for nondysplastic Barrett's is effective, it's safe, it's affordable, it's timely, and it's aimed at a group the cancer risk of which is higher than that for which we do other endoscopic interventions. Like I said, this is a group that's at a substantially higher risk of a more lethal cancer than are your colorectal cancer screening patients. So the only logical conclusion to everything I've shown you is to burn them all. It's not your job to save the insurance company's money and let God sort them out. Thanks for your attention.

Barrett's esophagus

ablation

esophageal adenocarcinoma

surveillance endoscopy

cancer risk