Patients with obesity who underwent endoscopic sleeve gastroplasty (ESG) along with lifestyle changes experienced more weight loss compared to lifestyle changes alone, and they also saw improvements in their comorbidities, a randomized trial found.
In a modified intention-to-treat analysis of 187 patients, those assigned to lifestyle modification plus ESG shed significantly more excess weight at 52 weeks compared to individuals who only underwent lifestyle modification (49.2% vs 4.5%), a difference that more than doubled the study’s threshold for success (P<0.001), according to Barham Abu Dayyeh, MD, of the Mayo Clinic in Rochester, Minnesota.
Average total weight loss was 13% greater at this time point in the ESG group (P<0.001) and these patients were able to maintain nearly all (91%) of the weight loss out to week 104 (average 12.4%), he said in a presentation at the Digestive Disease Week (DDW) annual meeting.
Additionally, the ESG group saw improvements in type 2 diabetes (93% vs 15% with lifestyle modification alone), metabolic syndrome (83% vs 35%), and hypertension (67% vs 40%).
ESG is a stomach-preserving endolumenal endoscopic procedure used as a therapeutic option for obesity. Safety and efficacy have been established in prior studies, but there remains a lack of consensus on technique, training, and pre- and post-procedure patient management, according to recent research.
“We need more interventions that are organ-sparing, safe, and effective,” Abu Dayyeh said, adding that these interventions should be easy to adhere to for patients, particularly during the pandemic.
“Endoscopic sleeve is a peroral procedure done with a full thickness suturing device to implicate the greater curvature of the stomach in order to alternate it into a tubular shape that affects appetite pathways,” he explained. “The procedure preserves the neurovascular supply of the stomach and its motility, therefore it is an anatomy-preserving option for weight loss and comorbidity management.”
In the trial, ESG was associated with significantly improved quality of life, eating behaviors, and depression, without any worsening of gastroesophageal reflux disease, and 80% reported that they would definitely recommend ESG to a friend or family member with obesity.
“This is an important study that shows ESG is very safe, effective, and durable to treat obesity, as well as very well tolerated,” commented C. Roberto Simons-Linares, MD, of the Cleveland Clinic in Ohio, who was not involved in this study.
“Patient satisfaction was very high,” he added. “Patients suffering from obesity and healthcare providers managing obesity and metabolic syndrome should be aware that ESG is a great option.”
The study randomized 208 adults with a body mass index of 30-40 (mean 35.7) at nine U.S. centers to “moderate-intensity” lifestyle modification with ESG for 52 weeks (n=77) or to lifestyle modification alone (n=110).
After 52 weeks, 72 patients from the control group crossed over to receive ESG and achieved similar weight loss outcomes as the initial ESG arm (44% excess weight loss).
ESG alone met its target threshold of 25% after showing an excess weight loss of 49%. The responder rate among ESG patients who achieved the excess weight loss threshold was 77%. Among responders, total weight loss was 16%.
Improvements in insulin resistance and hyperlipidemia were seen with ESG, the study found, with HbA1c significantly improving by a mean 1.65%.
Serious adverse events — perigastric abscess, an upper gastrointestinal bleed, and malnutrition — occurred in three patients (2%) in the ESG group, all of which resolved without sequelae or any deaths, and 4% were hospitalized for management of accommodative symptoms after the procedure.
Among those patients who did not meet the primary outcome, 14 underwent resuturing. None required other surgical interventions, blood transfusion, or intensive care.
Abu Dayyeh disclosed relationships with Apollo Endosurgery, Aspire Bariatrics, Boston Scientific, BFKW, Cairn, EndoGastric Solutions, Endogenex, GI Dynamics, Johnson & Johnson, Medigus, Medtronic, Metamodix, Olympus, Spatz, and USGI.