Latest / The Staple Line / Vol. 2, No. 15: Surgery and cancer, late clots after sleeve, and Revita after tirzepatide

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Vol. 2, No. 15: Surgery and cancer, late clots after sleeve, and Revita after tirzepatide · The Staple Line

• 0:00
  [on-hold music] Hello, welcome back to The Staple Line, the weekly audio edition of mbs-digest.com.
• 0:19
  I'm John Scott. This is volume two, issue 15. This week, a huge Nordic registry on surgery and cancer with one result that points the other way.
• 0:31
  Also, why blood clots after a sleeve can show up later than we usually look. Also, a company says that the procedure slowed weight regain after people stopped taking tirzepatide.
• 0:44
  And then, Europe takes a step in an oral GLP-1. Today, I'll keep the numbers light, and I'll tell you which findings are actually solid. The details are always in the issue. Let's get into it.
• 0:57
  Let's start in surgery research, and we're starting with cancer. Researchers in the Nordic countries looked at about eight hundred thousand adults with obesity.
• 1:07
  About a hundred thousand of them had bariatric surgery, and the people who had surgery had about twenty percent fewer obesity-related cancers. Is that significant? Yes.
• 1:18
  And since you'll hear that word a lot, statistically significant means unlikely to be a fluke. It doesn't mean big, and it doesn't mean it matters in practice, and I'll try to tell you both.
• 1:30
  This one held up, and it looked like it was about the same in younger and older adults. Now, here's the twist. Pancreatic cancer went the other way.
• 1:40
  Overall, it was about twenty percent higher after surgery, but that result only barely clears the bar for significance.
• 1:48
  In the under forty group, it was more than double, and that difference between the age groups was significant. So what do we do with that?
• 1:57
  This is registry data without BMI or lifestyle information, and people who have had the surgery may simply get looked at more. My read is this: The pancreatic signal needs replicating.
• 2:09
  It isn't evidence that surgery causes pancreatic cancer, and the lower overall rate is an association, not proof of prevention.
• 2:18
  And for cancers that occur in both sexes, the effect in men and women, taken separately, wasn't statistically significant. The second story is about timing.
• 2:29
  A big database analysis followed almost ninety thousand people for a year after a sleeve or a gastric bypass and counted a hundred and eighty-four clots in the portal and mesenteric veins.
• 2:41
  These are the veins that drain the gut. Compared with bypass, the sleeve came out at about three times the rate. That one is statistically solid. But here's what stood out.
• 2:54
  About three in ten of the clots after a sleeve weren't diagnosed until after the fourth week. By two months, more than eighty percent of the sleeve clots had been found, versus a little over half after bypass.
• 3:08
  So a thirty-day complication window misses part of the picture, especially after a sleeve. The catch, the database didn't have the anticoagulation dose, how long the people took it, or whether they took it at all.
• 3:23
  So this can't tell us if longer prophylaxis would prevent these later clots. As a disclosure, our board member, Phil Schauer, is a co-author on this paper, and I'm the one who suggested we read it.
• 3:35
  One more from this section on survival. A meta-analysis pooled about four hundred and fifty thousand patients across thirty-four studies.
• 3:45
  Twelve years out, about four percent of gastric bypass patients had died, versus about seven percent of people who didn't have surgery.
• 3:53
  In people with diabetes, the gap was wider, about two percent versus eleven percent in five years. That's a big gap, but these are mostly observational cohorts that differ in who was in them.
• 4:07
  So I'd call it a consistent survival signal, not a head-to-head, and not a basis of ranking one operation against another.
• 4:14
  [ambient music] Over in obesity science, the vote leader connects right to the cancer theme.
• 4:27
  A Nature Metabolism review pulled together more than two hundred studies covering about one and a half million cancers. Higher BMI was linked to nineteen of the twenty-five cancer types they looked at.
• 4:40
  And the links are not equal. For every five points of BMI, endometrial cancer risk was more than fifty percent higher. For glioma, about three percent higher.
• 4:51
  Both of these are statistically significant, which is a nice example of why significance and big are different things. Three percent is real, but it's small.
• 5:03
  It also found links for leukemia, non-Hodgkin's lymphoma, bladder cancer, and glioma that earlier major reports didn't have. It's a June paper, older than our usual window for articles, but the board voted it in,
• 5:18
  and the caution is what it isn't. These are associations with BMI. They don't tell us how much cancer risk in any particular weight loss treatment would undo. Next, a real-world look at digital care.
• 5:33
  A UK online program enrolled more than eight thousand women, nearly all of them on tirzepatide.
• 5:39
  By six months, they'd lost a little over fifteen percent of their body weight on average, and more than nine in ten were still in the program. The investigators reported no serious treatment-related side effects.
• 5:52
  Now the context. There's no comparison group here, so there's no significant or not to report. It describes one monitored program and only people with complete data.
• 6:03
  The companies that ran it, SheMed and eMed, have employees as co-authors and the patients paid out of pocket. So it can't tell us how much the delivery model added or how it compares with in-person care.
• 6:14
  [gentle music] In our technology section, a learning curve study on the Hugo surgical robot covering one surgeon's first 150 gastric bypass attempts.
• 6:31
  For roughly the first 17 cases, console time kept dropping fast, about nine minutes a case. After that, it flattened out. About 7.5% of patients had a complication, and there were no deaths.
• 6:45
  The catch, this surgeon already had laparoscopic bariatric experience, and the operating team had used Hugo before in urology before this series.
• 6:55
  So case 17 isn't the magic number other programs can borrow, and the study doesn't compare safety with laparoscopy. Now the one that's getting attention.
• 7:06
  Fractal Health put out a press release on Revita, an endoscopic procedure that resurfaces the lining of the duodenum.
• 7:13
  In a randomized, sham-controlled study of people who stopped tirzepatide, the Revita group regained about 5% of their weight at six months versus about 8% with the sham trial.
• 7:25
  The company says that's statistically significant, which works out to be three percentage points less regain. My read, it's modest, and it's only six months.
• 7:36
  No serious device or procedure-related side effects were reported. Now the fine print. This is a sponsor press release, not a peer-reviewed paper.
• 7:46
  The company also says longer treated stretches did better, but that was an after-the-fact subgroup comparison, so it's a hint, not a finding.
• 7:55
  And the 12-month result isn't in yet, so whether the effect lasts is still open. [gentle music] In the marketplace, Europe took a step on oral GLP-1s.
• 8:11
  The CHMP, the committee that advises the European Medicines Agency, adopted a positive opinion on October 15th for Eli Lilly's Fondeo, which is orforglipron, for adult weight management and for type 2 diabetes that isn't well controlled.
• 8:27
  The most common side effects are the usual stomach ones, nausea, vomiting, and diarrhea. What it isn't? A positive opinion is a recommendation.
• 8:37
  It is not an authorization from the European Commission, and it is not a decision on who pays. The Commission's decision is the next step.
• 8:46
  And in robotics, Stryker announced an investment of about $400 million in CMR Surgical, the company behind the Versius robot, plus exclusive U.S. sales rights and an option to buy all of CMR down the road.
• 9:00
  CMR keeps development and everything outside the U.S. Approvals and closing conditions still apply, so this is a proposed alliance, not a finished acquisition. [gentle music] Now for some quick hits.
• 9:18
  A small single-center study followed 35 women with insulin-treated diabetes after a sleeve with transit bipartition.
• 9:26
  Five years out, about two-thirds were off diabetes medication, but 27 of the 30 women with their original anatomy and complete data had at least one abnormal lab result, and about three in four were low on vitamin D.
• 9:40
  There was no comparison group, and the women were selected, so it can't separate the operation from who got it. The ASMBS review of AI that we covered in Issue 14 is back at the board's request.
• 9:51
  Eight recommendations, with AI framed as decision support and a call for prospective evaluation, since most of the evidence so far is retrospective. Disclosure again, board member Jerry Deng is a co-author of this study.
• 10:05
  Viking has started two Phase III trials on an oral version of VK2735, a dual GLP-1 and GIP drug, in adults with and without diabetes, about 560 in each trial running 68 weeks.
• 10:20
  That announcement is the start of the trials, not the results. And Zealand and Generant BioMedicines announced a collaboration on AI-designed proteins for obesity.
• 10:30
  $30 million up front, with potential milestones approaching $1.2 billion. It's discovery stage, so there's no human data yet. [gentle music] Now before we go, one thing.
• 10:49
  The MBS Digest runs on what this community sends in, and the submissions page is open at mbsdigest.com/submit.
• 10:58
  You can suggest an article, write a commentary of 600 to 900 words, or a letter to the editor of 200 to 400 words. Tell us about your program in a practice spotlight or tour, or pitch a poll question.
• 11:12
  And for this show, tell me who you'd like to hear me interview, and why now. Two ground rules, disclose any industry relationships because we publish them with the pieces, and keep patient information out of it.
• 11:25
  Our editorial board reviews every submission, and I'll write back either way. Once again, that's mbs-digest.com/submit, and the link is in the show notes. That's the staple line for Issue 15.
• 11:40
  Every source is linked in the show notes, and the full issue is free at mbs-digest.com. This is a summary of published evidence, not medical advice. Once again, I'm John Scott.
• 11:52
  Thank you for listening, and I'll see you next week. [outro music]