Abstract
We conducted a pilot study of a potential endoscopic alternative to bariatric surgery. We developed a Natural Orifice Transluminal Endoscopic Surgery (NOTES) gastric bypass with controlled bypass limb length using four new devices including a dedicated lumen-apposing metal stent (GJ-LAMS) and pyloric duodenal exclusion device (DED). We evaluated procedural technical success, weight change from baseline, and adverse events in growing Landrace/Large-White pigs through 38 weeks after GJ-LAMS placement. Six pigs (age 2.5 months, mean baseline weight 26.1 ± 2.7 kg) had initial GJ-LAMS placement with controlled bypass limb length, followed by DED placement at 2 weeks. Technical success was 100%. GJ-LAMS migrated in 3 of 6, and DED migrated in 3 of 5 surviving pigs after mucosal abrasion. One pig died by Day 94. At 38 weeks, necropsy showed 100–240 cm limb length except for one at 760 cm. Weight gain was significantly lower in the pigs that underwent endoscopic bypass procedures compared to expected weight for age. This first survival study of a fully endoscopic controlled bypass length gastrojejunostomy with duodenal exclusion in a growing porcine model showed high technical success but significant adverse events. Future studies will include procedural and device optimizations and comparison to a control group.
Highlights
In addition to lifestyle modifications, bariatric surgery (Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, biliopancreatic diversion or laparoscopic adjustable gastric band) is recommended for adult patients with BMI ≥ 40 or with BMI ≥ 35 with one or more severe obesity-related comorbidities, including type 2 diabetes mellitus or non-alcoholic fatty liver disease[1]
Since the 1980s when endoscopically placed intragastric balloons were introduced, endoscopic alternatives to bariatric surgery have been investigated to promote weight loss and improve metabolic parameters in obese patients who are ineligible for bariatric surgery, or as a bridge to surgery for patients who are anticipated to become eligible after presurgical weight loss[9]
The goal of the current exploratory pilot study was to demonstrate in a survival growing porcine model technical feasibility and safety of the fully endoscopic bypass procedure including 4 dedicated novel devices allowing natural orifice transluminal endoscopic surgery (NOTES) gastrojejunal anastomosis (GJA), measurement of the bypassed limb, duodenal obstruction
Summary
In addition to lifestyle modifications, bariatric surgery (Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, biliopancreatic diversion or laparoscopic adjustable gastric band) is recommended for adult patients with BMI ≥ 40 or with BMI ≥ 35 with one or more severe obesity-related comorbidities, including type 2 diabetes mellitus or non-alcoholic fatty liver disease[1]. Remaining challenges include optimizing the technique and associated devices for reliable creation of an endoscopic bypass. This includes reliable selection of the jejunal limb of a well-controlled length to maximize weight loss and metabolic effect, and creation of a reliable and durable GJA and duodenal exclusion. The goal of the current exploratory pilot study was to demonstrate in a survival growing porcine model technical feasibility and safety of the fully endoscopic bypass procedure including 4 dedicated novel devices allowing NOTES GJA, measurement of the bypassed limb, duodenal obstruction.
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