Percutaneous device aids weight loss in class II, III obese patients

Last Updated: 2016-12-27

By Reuters Staff

NEW YORK (Reuters Health) - A percutaneous gastrostomy device that siphons off about 30% of consumed calories improves weight loss in obese individuals, according to a new randomized controlled trial.

Patients randomly assigned to the AspireAssist device for 52 weeks lost 31.5% of their excess body weight, compared to 9.8% for those who received lifestyle counseling only (p<0.001). The findings were published online December 6 in The American Journal of Gastroenterology.

Only a small fraction of people who are eligible for pharmacotherapy or surgery to treat obesity receive it, in part due to the invasiveness of surgical methods, Dr. Christopher C. Thompson of Brigham and Women's Hospital in Boston and colleagues note in their report.

"These issues have led to increasing interest in developing endoscopic obesity therapies for patients who have not had successful weight loss with conservative therapies, but who do not qualify for, or desire, more invasive bariatric surgery," they write.

AspireAssist consists of an endoscopically placed percutaneous gastrostomy tube, a skin port, and an accessory device.

"The system permits instillation of fluid into the stomach and partial aspiration of ingested meals," Dr. Thompson and colleagues explain. It is intended for use along with lifestyle counseling. A pilot study found that obese patients lost one-third more weight when using the device compared to counseling only.

In the new study, 207 people with body mass indexes (BMIs) of 35 to 55 were randomized to the AspireAssist device plus lifestyle counseling or lifestyle counseling only at a 2:1 ratio. Mean BMI was around 40 in both groups. About three-quarters of the AspireAssist group completed the study, compared to roughly half of the lifestyle-counseling group.

After 52 weeks, 58.6% of patients who received the device had lost at least 25% of their excess weight, versus 15.3% of those in the counseling-only group (p<0.001). Patients given AspireAssist also had significantly greater improvements in glycated hemoglobin levels.

Common adverse events in the device group included peristomal granulation tissue (40.5%), abdominal pain within four weeks (37.8%), and nausea/vomiting or peristomal irritation (17.1% in both groups). About 90% of adverse events were related to the tube, and half occurred within the first week of placement.

"Despite the removal of a portion of ingested calories in the AspireAssist group, there was no evidence of a compensatory increase in food intake during or between meals to compensate for the reduction in energy intake," the researchers note. "This observation implicates central reward pathways and chronic lifestyle behaviors in driving food consumption."

They conclude: "The weight loss efficacy and safety profile of AspireAssist suggest this treatment approach may help bridge the therapeutic gap between more conservative lifestyle modification and the established bariatric surgical procedures for people with Class II and Class III obesity."

The study was funded by Aspire Bariatrics, Inc., which also employed two of the authors.

SOURCE: http://bit.ly/2injgWD

Am J Gastroenterol 2016.