Emerging endoluminal techniques and devices intended for weight loss therapy may reduce the risk of morbidity and mortality associated with current bariatric surgery approaches, according to the research findings of Dr. Philip Schauer and his associates.
The use of endoluminal approaches to avoid any type of abdominal incision and, more importantly, any intra-abdominal dissection “may go a long way to further reduce the morbidity of these operations, making them cheaper and safer,” said Dr. Schauer in an interview. “They may expand the access for patients. Only 1% of patients with severe obesity are actually getting access to surgery, which is the only known therapy to be effective for a large percentage of patients.”
Dr. Schauer, director of advanced laparoscopic and bariatric surgery at the bariatric and metabolic institute of the Cleveland Clinic, and his associates categorized the current endoluminal methods for weight loss therapy as presurgical endoluminal therapy, postsurgical endoluminal revision procedures, and primary procedures (Surg. Endosc. 2007;21:347–56).
In the presurgical endoluminal therapy arena, Dr. Michel Gagner and his associates pioneered a two-stage operation consisting of a sleeve gastrectomy followed by a Roux-en-Y gastric bypass (RYGB) or a duodenal switch (Obes. Surg. 2003;13:861–4).
“The rationale is that the first-stage operation, sleeve gastrectomy, is comparatively simple (requiring no anasto- mosis), needs less operative time (1–2 hours), and results in a predictable 40- to 50-kg weight loss,” Dr. Schauer and his associates wrote in their review. “Such weight loss reduces the operative risk for the second-stage procedure, which presumably results in more weight loss and greater durability.”
Dr. Gagner, professor of surgery and chief of bariatric surgery at Cornell University, New York, and his associates were also the first to publish results of an approach using the placement of endoluminal duodenojejunal tube or plastic sleeve to the first part of the duodenum proximal to the ampulla of Vater in pigs as a weight-loss strategy (Obes. Surg. 2006;16:620–6). This study, which demonstrated good weight loss in pigs, was the basis for the first human trial reported by Dr. Leonardo Rodriguez and his associates at the annual meeting of the American Society for Metabolic and Bariatric Surgery (formerly the American Society for Bariatric Surgery) in June 2007.
In the human trial, 12 patients from Chile and Brazil, including four with diabetes, underwent placement of a 61-cm endoluminal duodenojejunal tube or plastic sleeve that was anchored endoscopically in the duodenum and removed after 12 weeks. All of the patients achieved an estimated weight loss of at least 10%, and 10 of the 12 patients lost an estimated 24% of their weight. None of the diabetic patients required hypoglycemic medications.
“By diverting the flow of food from the duodenum and the proximal jejunum, we might be able to change some of the GI hormones that may switch the diabetes to reverse itself,” Dr. Gagner said.
In other studies of presurgical endoluminal therapy, the intragastric balloon developed by BioEnterics Corp. has been used successfully as a first-stage procedure to reduce presurgical weight and perioperative risk in superobese patients, but clinical results are limited.
In the arena of postsurgical endoluminal revision procedures, small studies of C.R. Bard Inc.'s EndoCinch suturing system and endoscopic suturing device have demonstrated promising results.
Dr. Christopher C. Thompson and his associates used the EndoCinch suturing system in eight patients who had undergone RYGB but had regained an average of 24 kg from baseline (Surg. Obes. Relat. Dis. 2005;1:223). At 4 months after undergoing the procedure, six of the eight patients had lost an average of 10 kg, and four reported significant improvements in satiety.
Such suturing procedures hold promise, Dr. Schauer said, because “they emulate gastric restriction, a concept that has been proven over several decades.”
Dr. Schauer disclosed that he is a paid consultant for Bard, Davol, Ethicon Endo-Surgery Inc., Stryker Endoscopy, Baxter International Inc., W.L. Gore & Associates Inc., and Barosense Inc.
Dr. Gagner disclosed that he is a scientific adviser for GI Dynamics Inc. He has also received research grants from Covidien AG, Olympus America Inc., and Bard.
With the flow of food diverted, GI hormones may change enoughto cause the diabetes to reverse itself. DR. GAGNER