Richard Whelan, MD, Professor of Surgery, area of expertise in colorectal surgery and endoscopy, affiliated with multiple hospitals including Mount Sinai Beth Israel Hospital and Mount Sinai Hospital, talks about a procedure called endoscopic submucosal dissection (ESD) for the removal of large polyps and lesions from the colon.
Interview conducted by Ivanhoe Broadcast news in October 2018.
I want to start by asking you about ESD, what does it stand for and if you could describe what it is for our viewers?
Dr. Whelan: Endoscopic Submucosal Dissection is a name for an endoscopic method which allows doctors to remove large polyps and lesions from the colon that otherwise would be very difficult to remove. Most polyps that we are seeing or many of them are shaped like a mushroom and they have a stalk and then a larger head; these are easy to remove. You just take a simple snare which is just a sheath with a wire, a round wire almost like a noose and you put it around the polyp and then you tighten the noose, put current through it, and you remove it. It’s that’s straight forward. If the polyp is very flat then that method does not work and the danger of using A snare on a flat thing is that you may perforate the bowel. If you perforate the bowel and the contents of the colon get in to the abdomen suddenly peritonitis WILL DEVELOP, it’s an emergency operation.
We were talking about ESD and the flat polyps, if you could tell me a little bit about that.
Dr. Whelan: Sure, so if the polyps are flat then a snare is dangerous because the current is likely to perforate the wall because the wall is very thin in the colon. ESD is a method invented by the Japanese to actually remove cancers in the stomach. The basic idea is that the bowel wall has multiple layers in it and you can inject fluid into the layer that’s right next to the layer where the polyp or the cancer might be. By doing that the layer will expand, it will pump fluid into it and lift it off the bowel wall. That creates a working space IN WHICH you can then use electric current through an endoscope (a colonoscope is an endoscope). So I say endoscope but THAT ALSO REFERS TO A colonoscope as well. You put current through that, through an insulated sheath, a little wire sticking out and it acts like a knife. And you can actually cut and make an incision. Whereas a snare polypectomy, what I described before, is actually just a gross method, it just strangles it and it coagulates. This ESD is an actual surgical procedure. The scope is being used to actually draw around the lesion and to cut the tissue layer by layer in order to get the polyp removed. One advantage of it is it gives you the entire polyp in one piece and that for the pathologist is very important. They can look at it and then say it’s fully resected and tell us how deep it invades IF, IN FACT, it is AN INVASIVE cancer.
So this procedure was done in other countries more frequently and not here?
Dr. Whelan: It started in Japan but it’s also now widely done in Korea, China, Singapore, and even in Europe it’s also beginning to gain some popularity. In the US though like Europe it’s a minority of patients that are being treated this way. There are a handful of GI doctors that are doing this and there are also a handful of surgeons that do endoscopy who are doing this. I fall into the surgery category.
Tell me why, if it’s so successful, it’s not picking up more steam or has it yet here in the US, what are the challenges?
Dr. Whelan: The main challenge is that it very, very hard to do it, and the skill set you need to do it is entirely different than the skill set that most endoscopists would have. The Japanese learned this by doing the procedures in the stomach. The stomach has very thick walls which means the chances of perforating the stomach are very small, so that’s a good place to learn. In Japan, they do sixty or so cases in the stomach before they let their doctors then try the colon. In the US we don’t have stomach cancer at that rate and certainly not early stomach cancers so it is impossible to train a US surgeon or US endoscopist to do this in the stomach. So we’ve come up with other training models that allow us to do this by using intestinal pieces from animals that have DIED and we can actually train that way. By doing that, thirty or forty times in that model we actually can then move into the human situation. The other challenge that we have is that there’s no BILLING code for this for EITHER the doctors OR the hospitals to get paid. The instruments that are used for this cost a couple thousand dollars, whereas a typical endoscopy would cost maybe three or four hundred dollars, maybe eight hundred dollars tops. The instruments are so critical to this; you must have them to do the procedure but the institution can’t bill for that. So what’s needed is a new code from Medicare to acknowledge that this procedure is different and it can take several hours to do this. It’s not a fifteen minute thing, these can take quite a while to do.
What’s the benefit to the patient?
Dr. Whelan: The benefit for the patient is the fact that in most cases they can go home either that day or the next day. In our case we keep them overnight and they go home the next day. The alternative would be to have a colon resection done. The colon resection would be done laparoscopically in this day and age but the patient would still be in the hospital three to five days. And there’s about a one to two percent chance of THE PATIENT developing a leak, which is a big abscess or problem in the belly. There is a one point five percent mortality rate if you look at the large databases in the US that PROVIDE us WITH this information. So of the twenty eight thousand patients I mentioned who get this procedure for a benign polyp, three hundred and fifty would be predicted to unfortunately pass within thirty days. The endoscopic alternative we’re discussing, this ESD process, HAS A mortality from that is one in ten thousand to one in twelve thousand patients. Also if you look at overall costs, the cost of a hospitalization and a colectomy in terms of the other equipment that’s needed for that and you compare that to the cost for this endoscopic procedure, THE FORMER is about forty thousand and the other one is maybe six or seven thousand dollars. THUS, the system would also save money. SO, ESD IS something that makes sense from the patient’s point of view, it’s a choice of having your colon taken out, a piece of it, versus an endoscopic procedure done in a endoscopy suite or an operating room and go home the next day. It’s a pretty easy choice.
How many ESD’s are done the United States?
Dr. Whelan: It’s very hard to put a number on that but if there are twenty eight thousand being done surgically, which is the data from about a year and a half ago, maybe about two thousand ARE DONE VIA ESD NOW maybe? But I’m making this up. I know in the New York City area there are only about three people that are doing this very commonly in terms of a true ESD procedures and the same is true for most major cities. Many hospitals do not have anyone doing this procedure. Again, the training is one issue and the other thing is the reimbursement part of this. Also just publicity and people understanding that there may be an alternative to SURGICAL COLECTOMY.
From your perspective, what needs to happen and what plans are already in place, what kind of things have you done to try to improve these numbers, see if more people can have access to this?
Dr. Whelan: Well for one thing we’re training; we actually do one or two PRACTICE sessions a week. We’re training using models that don’t involve people. So we can use a piece of intestine from another source IN A COLON MODEL and we can learn IN THAT WAY. The second thing is we’re developing training programs nationwide for our young doctors. This is true both in the gastroenterology world and also in the surgical world. Also we’re trying to get attention to the fact that there’s real healthcare savings and a huge patient benefit if we could get this widely implemented across the country so we’re trying to get attention to that as well.
What are the healthcare savings again, is there any estimate on how much a year this could save the system?
Dr. Whelan: I know per case it’s about forty thousand versus about six thousand, you’d have to just work out the math on that but I think it’s a fair amount of money. More importantly besides the fact that we can treat patients who have benign polyps, large benign polyps that are flat, which is the target lesion for this, HOWEVER WE also can treat SOME cancers this way. Cancers that are very early stage, that have just invaded a small amount into the first layer beyond the mucosal layer where they live, those can also be treated this way without the need for a subsequent operation. So there’s a subset of people who have stage one cancers where they’re very superficial cancer and if they are removed using this method the pathologist will be able to say how far it invades into the wall. If it invades just a short distance then the Japanese have shown that there’s no need to do a colon resection. The patients who just have the endoscopic procedure alone, five years later have the same survival rate, which is about ninety five percent, as do patients who undergo the major operation. So there’s a promise also for early cancers of avoiding the surgical procedure as well. That might bring the numbers up in the US to forty thousand cases a year.
Is this primarily then for the benign polyps? Are you using it for stage one cancer just to clarify?
Dr. Whelan: Our intention is to use it for benign polyps. But if we get sent patients who have large benign polyps about ten to fifteen percent of those people turn out to actually have a cancer. And we may not be able to determine that upfront we may have done the resection already and in that case you’ll be able to then evaluate that and consider that. Currently in our program, were still doing the colon resection for this. We’re just getting our skills to the point where WHERE WE AREe doing this now regularly on a weekly basis, succeeding with this. With time I think also our pathologist will get better used to this, to what they have to do. There’s a whole different way of looking at the specimen. I think soon we will be able offer that for these early cancers but our target populations for this are people that have benign polyps that are large. Where the GI doctor has said that they don’t think they could get it out that way, and they often will send the patient to a surgeon to have a colon resection done.
Is there any particular place in the colon or is it the entire colon that you can use the ESD?
Dr. Whelan: You can use it anywhere in the rectum or in the colon, polyps in the US are more often found in the right side but they can be in any piece of the colon as well. The difference of a surgeon doing this versus the GI doctors, because both doctors if they have the skills can do it, it’s just that if we suspect a cancer while we’re doing an endoscopy and the patient has taken bowel preparation that we can go ahead and do the colectomy immediately if we HAVE discussED it with them before hand. We will consent patients for both the endoscopic procedure, the ESD or if that’s not possible a bowel resection, and there’s even a third possibility of trying to take just a corner of the bowel, a partial piece of the circumference to get the polyp out. It will give patients options but it hopefully will and should almost always lead to a resolution of the problem in one session.
How long do you think it would be in your estimation before we have a paradigm shift? And would you ever see it?
Dr. Whelan: Yeah, I think that once we have a procedure code that will allow the hospitals to justify paying these added costs and also the procedure code for the doctor, because doctors also put two or three hours in this and get paid as if they did a fifteen minute endoscopy. Once those things happen, I think we’ll see this happen quickly. There’s also new technology that’s coming in, it’s American designed equipment, which gives and provides an operative platform. We’re working right now with a few new devices that make this much easier. However, the costs of these are three to four thousand dollars for a device. So you add that to the fifteen hundred, two thousand for the other and unless there is a code and recognition of the benefits to the system IT WILL BE COST PROHIBITIVE. THE ADVANTAGES ARE obvious to the patient AND ALSO TO the medical system in avoiding hospitalization and also decreases the overall cost. Until that happens, I think it’s going to grow slowly but once we get to that point I think it will happen very quickly.
Is there anything I didn’t ask you that you want to make sure the people know?
Dr. Whelan: Why the surgeon is doing this. The idea as a surgeon if we can’t remove it through the colonoscope, which is the case in at least fifteen percent of cases, that we can at that time immediately do the colon resection because we will have discussed with the patient the possibility that IF we can’t get it out or that the frozen diagnosis of the tissue removed shows that there is a cancer present or something more WORRISOME, THEN THE COLECTOMY CAN BE DONE IMMEDIATELY.. So THE IDEA of one-stop shopping for patients IS ATTRACTIVE.
Instead of having to come back again?
Dr. Whelan: I mean otherwise if you do it in an endoscopy suite and the doctor says, I don’t think I can do this, and he tries and fails. Then you have to wake up, get the name of another doctor, another consultation, another bowel preparation, another set of tests. And so it just lengthens the procedure where this can be done in just one setting.
How long have you done this procedure?
Dr. Whelan: We’ve been working on this for about ten years, the procedure. But it really began to take off when we came up with this training model. The idea of if you’re an athlete you need to train, you can’t go to the Super Bowl if you don’t play football every day. So BEFORE WERE doing procedures maybe once a month and it’s hard to learn that way. So we set up this TRAINING model and we did sixty of them over the course of five months and we continue to do that. By training our team and repeating the procedure over and over again we got very comfortable with this. Now that we can in the human setting it’s just another day doing another case. I think for the US that’s a critical way to get around this problem, because it’s first of all safe because there’s no patient involved in the training and when you’re ready you move into the clinical setting. And the success rate I think will be much, much greater than if you just practice once or twice and then just start doing this on a person, which is not the way to do it.
Did you do any training in Japan?
Dr. Whelan: Yes. I’ve gone to Japan twice and spent some time with some brilliant doctors who were doing this. They’ve taught us quite a bit but the new technology coming down the line will make this a lot more accessible to other doctors as well.
About how long do you think for that?
Dr. Whelan: It depends on the coding. If they get the codes to justify the expenditure for the equipment and then for the doctor, I think probably within five years you would see a huge shift.
It’s always the red tape, right?
- Whelan: Well yeah, it’s really hard to get things passed. There are so many NEW PROCEDURES and COMPETING FOR NEW CODES . BECAUSE it’s twenty eight thousand patients it’s not AS LARGE A NUMBER AS FOR OTHER DISEASES, IT IS DIFFICULT TO GET THE NECESSARY ATTENTION TO OBTAIN THE NEW CODES.
END OF INTERVIEW
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