Good afternoon from Houston. I'd like to thank the course organizers for the opportunity to present this rebuttal. It's not easy to debate against the master, Mouin Keshab M.A.S.G.E. This really is like a David versus Goliath challenge, so I will try my best to convince you that duodenal stenting is still the time-tested therapy in 2022. These are my relevant disclosures. When we think about duodenal stenting, it's important to understand the bigger picture. In this case, the bigger picture is that pancreatic cancer is the fourth leading cause of cancer-related deaths in the U.S. Surgery is the only potential curative treatment. However, the prognosis is poor even for those patients who undergo surgical resection. The five-year survival for node-positive disease is only 10%, and the five-year survival for node-negative disease is only 30%, and two-thirds of patients with a new diagnosis will present with lymph node metastasis. The other big-picture issue here is that approximately 15 to 25 percent of pancreas cancer patients will develop malignant gastric outlet obstruction, which then portends a poor prognosis. Seen here on the figure, the development of malignant gastric outlet obstruction results in a median survival of only three to four months from the time of diagnosis. In general, our management options for outlet obstruction include duodenal stenting to maintain patency, GJ to achieve bypass, or venting gastrostomy to achieve decompression. It's important to note that while duodenal stenting may not be the cool new kid on the block, it has a long track record to support its efficacy. It has been around for over 15 years with three RCTs and multiple observational studies showing benefit. In fact, ASGE recently put out guidelines on malignant gastric outlet obstruction. They did their own literature review which showed that when comparing duodenal stents versus surgical GJ, there were no differences in success, major adverse events, or post-operative mortality. Stents were associated with shorter resumption of oral intake and hospital length of stay, whereas GJ had lower re-intervention rates. As a result, the ASGE notes that either approach is appropriate and a shared decision should be made in consideration of the patient's life expectancy. So what is fundamentally wrong with stenting? As you can see here from our own paper, the problem has to do with stent occlusion and malfunction due to gradual tissue and tumor ingrowth. When we compare the techniques, we found that EUSGJ had higher clinical success and duodenal stents had higher incidence of stent failure requiring re-intervention. But if you look more closely at our study results, you'll find that most stents still last six months. Now when you look at the reality of pancreatic cancer, you'll realize that median survival is 8.7 months even for early stage pancreatic cancer and drops to 2.9 months for stage 4 disease. So then when you overlay these statistics, you realize that malignant gastric outlet obstruction has a median survival of three to four months and tumor ingrowth occurs at about six months. Therefore, sadly but realistically in most cases, the stent will outlive pancreatic cancer patients. So what about EUSGJ then? These are the results from a recent meta-analysis which looked at four retrospective and one prospective study on EUSGJ. He demonstrated a technical success rate of 92.9 percent, clinical success rate of 90.1 percent, and serious adverse event rate of 5.6 percent. The re-intervention rate was 11 percent. Dr. Kashab just presented compelling results in favor of EUSGJ in his side of the debate, but I call into question whether EUSGJ needs a bit of a reality check. Let's start by talking about advanced endoscopy fellowship training. As you can see on the graph on the right, there are roughly 70 or so positions available through the ASGE match every year. So out of the 70 fellows, how many do you think actually got to do EUSGJ during their training? Furthermore, even if they did, how many do you think actually felt comfortable performing the procedure in subsequent independent practice? You have to consider the stakes here for a junior faculty, that a complication can be either fatal or result in the inability of the patient to start or continue cancer treatment. And so there's a fundamental problem here. A mainstream procedure needs to be democratizable, but adoption of EUSGJ remains extremely limited, largely to tertiary centers of excellence. Existing studies therefore likely overestimate the true uptake of EUSGJ as a mainstream endoscopic procedure. Arguably, better instrumentation may change this balance, but it really gets to the heart of this debate, the question of how many people actually perform EUSGJ? If you consider this following figure that I'm quite proud of, you can see here that this big bubble represents the total number of advanced endoscopists. The next bubble includes the number of endoscopists who claim to do EUSGJ. The next bubble includes the number of endoscopists who actually do EUSGJ. The next bubble include endoscopists who are experts in EUSGJ. And do note that the size of these bubbles are not to scale. And then you have the legend, Dr. Kashab at the head of the rocket ship. And Dr. Kashab himself recently published his own learning curve in GIE last year. As you can see, the learning curve for EUSGJ is extremely steep. He demonstrated that 25 cases were needed to achieve proficiency and 40 cases were needed to achieve mastery. It's really important to know that individual results may vary. It's almost guaranteed that the average advanced endoscopist like myself will need more cases than the master to achieve the same results. Furthermore, it took six years for Dr. Kashab at Johns Hopkins to accumulate 87 cases. How many years do you think will it take you to accumulate 40 cases? Breaking down Dr. Kashab's paper, you will see that 87% of gastric outlet obstructions were malignant. The mean length of follow-up was 86 days, so approximately three months. And then notice that at three months follow-up, which includes both benign and malignant etiologies, only 59% of patients were still alive. Therefore, in other words, most of the malignant patients were dead at three months. And then there's the feared immediate adverse events. Now overall, the adverse event rates were low in Dr. Kashab's expert hands, with 6.5%, all of which occurred in the first 39 cases. But consider this though, patients who have malignant gastric outlet obstruction, these are terminally ill patients who are really anxious to start treatment. Adverse events delay treatment, and only 59% of all comers, including benign and malignant etiologies, were alive at three months. It really makes you wonder, wouldn't a duodenal stent make more sense? The author's own acknowledgment also stated, our analysis may underestimate the number of procedures needed for proficiency and mastery of the freehand EUSGE for operators with no prior EUSGE experience. So a really big disclaimer here that individual results may vary. Finally, realize that endoscopic innovation doesn't occur in a vacuum. At the same tertiary care centers of excellence, surgical techniques are constantly advancing. Many of the comparison papers compare EUSGJ to open surgical GJ, a comparison that simply isn't relevant or fair anymore. And new minimally invasive surgical techniques may have inherent advantages with better control of the operative field and potential complications. Consider this video from our institution of a robotic gastrointestinaloscopy. I will stay mostly quiet while you appreciate the video and the elegance of the surgical procedure with complete control of the operative field, which prevents potential complications or spillage of enteric contents. And you can see a robust hand sewn anastomosis being created here. In total, the OR duration was 86 minutes with 5 milliliters of estimated blood loss. The patient resumed oral intake on post-operative day 1 and was discharged on post-operative day 5. So that, you can see here, is the real competition. So in conclusion, duodenal stents or EUSGJ. Well, it's really not that one is necessarily better than the other. More so, this is like comparing apples and oranges, and the precise method should be tailored to the patient in a personalized approach. My argument here is that duodenal stent placement is still perfectly reasonable in 2022. Why? Pancreatic cancer prognosis is still poor. Most patients will unfortunately not live long enough for the stent to fail, and therefore decisions on the management of gastric outlet obstruction should be tailored in a multidisciplinary fashion. Furthermore, robotic GJ directly competes with EUSGJ. It may be preferred for patients who have reasonable long-term survival given that minimally invasive surgery allows for a controlled operative environment against leaks and perforations. And this is really the true competition. As you can see the graph on the right, robotic surgery cases seem to continuously increase in volume after a hospital decides to adopt the technology. So therefore EUSGJ occupies a very narrow middle ground niche, and until endoscopic tools significantly improve, the procedure simply isn't easy and safe enough to be widely adopted in a democratized fashion. And I'll just end with a philosophical observation here that a mainstream procedure really shouldn't consistently provoke an adrenaline rush. I therefore rest my case. Thank you for your attention.

duodenal stenting

pancreatic cancer patients

EUSGJ

robotic surgery

personalized treatment