StomaphyX Fails to Reduce Regained Weight After Roux-en-Y Gastric Bypass
By Will Boggs MD
February 28, 2014
By Will Boggs MD
February 28, 2014
NEW YORK (Reuters Health) - Revisional endoscopic surgery using the StomaphyX device does not adequately reduce weight regained by Roux-en-Y gastric bypass (RYGB) patients, according to results from a placebo controlled trial.
Patients typically lose 60% to 70% of their excess weight after RYGB, but five to ten years later, 20% to 50% of patients have gained back a significant amount. In several open label series, patients treated with StomaphyX have safely lost the weight they regained after RYGB.
Now, in a randomized trial, Dr. George M. Eid from the University of Pittsburgh Medical Center and colleagues evaluated the efficacy and safety of endoscopic gastric plication using the StomaphyX procedure in 90 patients who had regained weight after their RYGB.
"On the basis of retrospective data, we anticipated that 50% or more of the patients would achieve a clinically significant reduction in regained weight (at least 15% of excess BMI loss and BMI less than 35)," the authors wrote in a report online February 19th in JAMA Surgery.
But in fact, they had to stop the trial early, when preliminary data indicated that they couldn't meet the primary end point of clinically meaningful weight loss in at least 50% of patients after treatment.
Although StomaphyX successfully reduced pouch and/or stoma size in 53 of 55 treated patients, only 10 of 45 patients (22.2%) experienced a decrease of at least 15% of their excess body weight at month 12 (compared with one of 29 patients (3.4%) in the sham procedure group).
There was no difference between the treatment groups in the percentage of patients who achieved clinically meaningful improvements in quality of life.
The only adverse event causally related to the StomaphyX procedure was a serious gastric perforation that required laparoscopic exploration and repair, after which the patient recovered fully.
"Future studies may want to include follow-up evaluations with endoscopy to verify maintenance of pouch or stoma reduction and explore the benefits of using more durable suturing mechanisms," the investigators say. "Future work may also be needed to identify whether weight reduction maintenance is differentially affected when these interventions focus on reducing pouch versus stoma size."
Dr. Jon C. Gould from the Medical College of Wisconsin, Milwaukee, Wisconsin wrote an invited commentary related to this report. He told Reuters Health by email, "The current role of endoscopic revisional procedures for weight regain after gastric bypass has yet to be defined. These procedures are investigational in my opinion, and should be conducted in a well-designed clinical trial."
"The main message I would like to convey is that we need to be thoughtful as a bariatric community as we evaluate these devices," Dr. Gould concluded. "Just because a particular device is commercially available, doesn't mean we should be offering it to patients outside of a clinical trial - especially when long term efficacy data is lacking (typically the case)."
Dr. Vinay Goyal, a fellow in bariatric surgery at Penn State University/Milton S. Hershey Medical Center in Hershey, Pennsylvania, had similar findings in a study published in 2013. He told Reuters Health by email, "I cannot think of any definitive role for this procedure supported by clinical evidence in these patients. Theoretically patients with a lot of comorbidities who cannot withstand a long revisional procedure but are in need of a modest short term weight loss may be candidates for this procedure. This is obviously a very select group."
"At this time revisional surgery, either laparoscopic or open, remains the mainstay for such patients," Dr. Goyal said. "Endoscopic procedures like StomaphyX, ROSE, Endostitch, etc. remain investigational, showing little clinical benefit."
"The fact that this randomized trial had to be terminated prematurely due to lack of efficacy at one year is a pretty good testament to the fact that this procedure does not work," Dr. Goyal said.
Dr. Eid did not respond to a request for comments.
JAMA Surg 2014.