Roux-en-Y gastric bypass (RYGB) is effective for treating obesity and its comorbidities, but weight regain is common. Endoscopic transoral gastric outlet reduction (TORe), a minimally invasive procedure, has become a common treatment approach. It is performed to reduce dilation of the gastrojejunal anastomosis (GJA) and/or elongation of the pouch, which have been linked to the amount of weight gain.

Currently, two types of devices are FDA-approved for TORe:

• For suturing—Overstitch (Apollo Endosurgery, Austin, TX)
• For plication—Incisionless Operating Platform (IOP) (USGI Medical, San Clemente, CA)

Suturing involves folding the tissue in a mucosa-to-mucosa fashion, whereas in plication TORe (P-TORe), the tissue is folded serosa-to-serosa, allowing gastric mucosa to stay within the lumen.

A meta-analysis published in Obesity Surgery has demonstrated that performing argon plasma coagulation (APC) around the GJA prior to suturing or plication may lead to greater weight loss than with suturing or plication alone.

Endoscopists at Brigham and Women’s Hospital have conducted the first study in which P-TORe was combined with APC to treat weight gain after RYGB. Pichamol Jirapinyo, MD, MPH, associate director of bariatric endoscopy in the Division of Gastroenterology, Hepatology and Endoscopy, and Christopher C. Thompson, MD, MSc, director of endoscopy and co-director of the Center for Weight Management and Wellness, report in Gastrointestinal Endoscopy that the procedure was technically feasible, safe and effective. The majority of patients achieved a prespecified threshold for clinically significant weight loss.

Methods

The researchers analyzed prospectively collected data on 111 patients at the Brigham who had inadequate weight loss (<50% of excess weight was lost) or weight regain (≥15% of maximal weight initially lost) after RYGB. Between October 2017 and July 2021, they underwent P-TORe using the second-generation IOP system and had APC performed on the gastric side of the GJA prior to plication.

All patients were directed to moderate lifestyle intervention after the procedure.

Efficacy

The primary outcome was the amount of weight loss at one year:

• Weight gain prevented—89% of patients
• The number needed to treat to prevent weight gain—1.1
• Average absolute weight loss—10.4 kg (corresponded to 9.5% total weight loss; P<0.0001)
• Clinically significant weight loss (at least 5% total weight loss)—73% of patients

Safety

Moderately severe adverse events occurred in 14 patients (13%). These included GJA stenosis (n=11), melena due to marginal ulceration at the prior APC site (n=2), and deep vein thrombosis (n=1). There were no severe or fatal adverse events.

Predictors of Weight Loss

In univariable linear regression analyses, positive predictors of percent total weight loss at one year were:

• Amount of weight regain (β, 0.09; P=0.03)
• Pouch length (β, 1.06; P=0.05)

In multivariable analysis, the amount of weight regain remained a significant predictor of percent total weight loss (β, 0.09; P=0.03).

Reducing the Risk of Stenosis

At the beginning of the study, 80-watt APC was used, which was associated with a 32% rate of stenosis. This prompted a reduction in APC power to 70 watts. The stenosis rate dropped to 5% and there did not appear to be any effect on weight loss. All cases of stenosis were treated successfully with endoscopic intervention.