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ASGE task force: New endoscopic bariatric therapies effective for treating obesity
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A systematic review and meta-analysis performed by the ASGE Bariatric Endoscopy Task Force and the ASGE Technology Committee Chair determined new endoscopic bariatric therapies provide an effective, minimally invasive alternative for treating obesity.
“Endoscopic bariatric therapies offer a viable, safe alternative for patients who have been unsuccessful at weight loss with diet and exercise,” Christopher C. Thompson, MD, MHES, FASGE, chair of the ASGE Bariatric Endoscopy Task Force, said in a press release. “They may also be appropriate for patients who are not suitable for, or are unwilling to undergo, a more invasive surgical procedure.”
To determine whether available endoscopic bariatric therapies meet the ASGE PIVI performance thresholds, the task force reviewed the literature published from 1988 through December 16, 2014, and found sufficient data were available for the BioEnterics Intragastric Balloon (Allergan), currently known as the Orbera Intragastric Balloon (Apollo Endosurgery; 82 studies included), and the EndoBarrier duodenal-jejunal bypass sleeve (GI Dynamics; 11 studies included).
The task force determined the Orbera Intragastric Balloon meets the PIVI thresholds for primary and nonprimary bridge obesity therapy. A meta-analysis of 17 studies (n = 1,683) showed 12-month excess weight loss was 25.44% (95% CI, 21.47%-29.41%), and three randomized controlled trials showed a mean difference of 26.9% (95% CI, 15.66%-38.24%) in percentage of excess weight loss compared with controls. The pooled percentage of total body weight loss was 12.3% (95% CI, 7.9%-16.73%) at 3 months after implantation, 13.16% (95% CI, 12.37%-13.95%) at 6 months and 11.27% (95% CI, 8.17%-14.36%) at 12 months.
Despite more limited data, the task force also determined the EndoBarrier duodenal-jejunal bypass sleeve appears to meet the percentage of excess weight loss PIVI threshold at 12 months (35%; 95% CI, 24%-46%), but not the required 15% excess weight loss vs. controls. Both devices had 5% or lower incidence of serious adverse events, indicating good safety profiles based on PIVI thresholds.
The task force will “await review of the pivotal U.S. trial data to determine the efficacy and safety of the EndoBarrier [duodenal-jejunal bypass sleeve],” the authors wrote. “Newer [intragastric balloons] such as the ReShape Duo and Spatz [intragastric balloons], aspiration therapy, endoscopic gastroplasty techniques, and other [endoscopic bariatric therapies] reviewed in detail in a status evaluation report on this topic are also undergoing studies at this time with insufficient data to include in this meta-analysis.”
This review follows the recent FDA approvals of the ReShape Integrated Dual Balloon System (ReShape Medical, Inc.), approved on July 29, and the Orbera Intragastric Balloon, approved on August 6, according to the press release.
“The ASGE is pleased that the FDA has approved these new devices and looks forward to providing the support and education that will allow our members to use these devices as part of a multidisciplinary weight management program in patients with obesity,” ASGE President Douglas O. Faigel, MD, FASGE, said in the release. “Gastrointestinal endoscopists will have an important role to play in combatting this difficult and growing epidemic.” – by Adam Leitenberger
Disclosure: Thompson reports he is a consultant for Boston Scientific, Covidien, Beacon Endoscopic and Apollo Endosurgery; has received lab support from Olympus, a research grant from Aspire Bariatrics, and has an ownership interest in GI Windows. Please see the full study for a list of all other authors’ relevant financial disclosures.
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