Endoscopic sleeve gastroplasty induces, maintains weight loss in mild, moderate obesity
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Endoscopic sleeve gastroplasty safely induced and maintained weight loss and improved metabolic comorbidities in patients with class 1 and class 2 obesity, according to research published in The Lancet.
“Endoscopic sleeve gastroplasty (ESG) is a procedure that is performed through the mouth with an endoscope to reduce the size of the stomach for weight loss and metabolic improvement in diseases such as diabetes,” Barham K. Abu Dayyeh, MD, MPH, director of advanced endoscopy and professor of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minnesota, told Healio. “This procedure does not require surgery and preserves the stomach; unlike surgery, the stomach is not cut and removed. Thus, the procedure is an appealing, minimally invasive option for many patients suffering from the disease of obesity.
“While hundreds of publications and abstracts have been published on experience with ESG, there remained a need for a prospective, randomized control trial demonstrating efficacy over a control group, according to joint medical and surgical guidelines dating back to 2011,” he said. “We also needed a better understanding of the impact of the procedure on obesity-related comorbidities.”
In the Multicenter ESG Randomized Interventional Trial (MERIT), Abu Dayyeh and colleagues explored the safety and efficacy of ESG along with lifestyle modifications compared with lifestyle modifications alone. The primary endpoint was percentage of excess weight loss (EWL) at 52 weeks, while secondary endpoints included change in metabolic comorbidities between groups. Patients in the control group who did not reach the EWL goal of at least 25% weight loss were offered ESG, with follow-up for an additional 52 weeks after crossover. Patients in the ESG group were monitored for 104 weeks.
Of 187 participants included in the modified intention-to-treat analysis, 77 underwent ESG with lifestyle modifications and 110 underwent lifestyle modifications alone. At 52 weeks, 49.2% of patients in the ESG group and 3.2% of patients in the control group met the primary endpoint, with a mean percentage of total body weight loss of 13.6% and 0.8%, respectively.
Compared with the control group, a higher percentage of patients in the ESG group also reached 25% or more of EWL (77% vs. 12%) and had an improvement in one or more metabolic comorbidities (80% vs. 45%). However, 12% of patients in the ESG group and 50% of patients in the control group experienced worsened comorbidities.
As is often seen with traditional bariatric surgery, Abu Dayyeh noted that patients with conditions like diabetes, hypertension and metabolic syndrome showed clinically meaningful improvement, with “additional improvements in eating behaviors, depression and quality of life” observed.
Among 60 patients in the ESG group who reached at least 25% EWL, 68% maintained that weight loss at 104 weeks. Further, the weight loss trajectory among patients who crossed over to the ESG group also improved, with participants reaching a mean 44.1% EWL at 52 weeks from crossover. Serious ESG-related adverse events occurred in three out of 131 participants.
“Studies looking at cost-efficacy of this endoscopic procedure over traditional surgical options could have significant impact on the way insurance companies view this as an option for patients with obesity,” Abu Dayyeh said. “Further research should also focus on combination therapies with pharmacotherapies and ESG together to have an even more profound impact on weight loss and comorbidities improvement.”
He continued, “ESG has opened an opportunity for providers and their patients who are struggling with obesity, many of whom have tried and failed to lose weight through changes to diet and lifestyle and are not interested in or candidates for bariatric surgery. We now have a procedure that is not only less invasive but also safe, effective and, importantly, organ-sparing.
“As gastroenterologists and surgeons, we now have the opportunity to offer an endoscopic procedure to patients that does not require the permanent removal or alteration of the GI tract, yet produces significant weight loss and metabolic benefit.”
Perspective
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It is well known now that ESG is a safe procedure to treat obesity — not only mild obesity (class 1) but also moderate obesity (class 2), as this research points out.
The MERIT trial is an excellent randomized study that demonstrates the efficacy and safety of ESG, as has been reported by other studies. The bottom line is that the ESG procedure works to treat obesity and is very safe. Of note, ESG does not cause GERD, as seen in surgical sleeve gastrectomy.
The study points out that at 52 weeks, patients who underwent ESG achieved significant weight loss and improved comorbidities, such as high blood pressure and diabetes, compared with lifestyle modifications alone for the treatment of obesity.
While ESG is a great tool, treating obesity and metabolic syndrome is not one size fits all. That is why it is important to work with a multidisciplinary team and include health care providers who care for patients with obesity and metabolic syndrome to help determine the best therapy for each patient and deliver a personalized approach.
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