CHICAGO — Two new studies cast doubt on the utility of one of the hottest new treatments for gastroesophageal reflux disease: the endoluminal gastric plication procedure known as EndoCinch.
Both studies were sham-surgery studies presented at the annual Digestive Disease Week.
Until now, there have mostly been highly positive reports from uncontrolled case series on the procedure, approved in 2000. One positive, small clinical trial was reported at Digestive Disease Week last year.
“It's quite amazing that thousands of these procedures have already been done,” said one of the study investigators, Matthijs Schwartz, M.D., at a press briefing.
“Probably, we should stop doing this procedure and wait for it to be improved,” Dr. Schwartz added.
The main investigator for the other study, Per-Ola Park, M.D., was similarly blunt. “Our conclusion from our study is that the EndoCinch procedure should not be used,” he said.
In Dr. Park's study, 47 patients with symptomatic gastroesophageal reflux for at least 1 year were randomized to receive either the EndoCinch procedure or a sham endoscopy. The patients were followed for 1 year.
All but 3 of the 22 patients who had the EndoCinch procedure experienced disease relapse, and almost all of those had relapse within 1 month of the procedure. In fact, there was no significant difference in time to relapse between the two groups, with about 80% of the patients in both groups experiencing relapse within a month.
The remainder of the sham-endoscopy patients had relapse after 1 month, said Dr. Park of Sahlgrenska University Hospital, Gothenburg, Sweden.
Relapse was defined as the need for proton pump inhibitor relief for heartburn, more than 1 day of severe heartburn, 2 consecutive days of moderate heartburn symptoms, or 3 days of mild symptoms.
At 12 months, there was no difference in ambulatory 24-hour pH monitoring, drug use, or health-related quality of life.
Dr. Schwartz's study found that patients who received the real procedure had a reduced need to use a proton pump inhibitor for the first 3 months after the procedure, relative to the sham-treated patients.
But there was no improvement in regurgitation frequency or severity or in esophageal acid exposure, relative to the sham group.
The study included 15 patients who underwent the procedure, 17 patients who had a sham endoscopy, and 13 patients who served as a second control group. It is well known that sham-treated patients in such studies often do quite well, noted Dr. Schwartz, director of endoscopy at the University Medical Center, Utrecht, the Netherlands.
Even though his study found a reduction in proton pump inhibitor use—the study's main outcome—Dr. Schwartz said he was skeptical of that result because it was only for 3 months. “I've seen many of these patients after 3 months, and many do relapse,” he said.
Although both investigators urged caution about continued clinical use of the procedure, both also said they were fairly sure that the procedure could be improved.
Dr. Schwartz noted that in his study, the investigators used three plications to create pleats in the gastric cardia, as has become common clinical practice. But previous studies have used four or five, and in his practice, he has gone back to add plications in patients who have not had a good initial result.
Dr. Park said he would still like to see the EndoCinch procedure be made to work because it is reversible, unlike some of the other gastroesophageal reflux procedures, such as the Stretta procedure, which uses microwaves to create scar tissue.
“Perhaps if we come back with more sutures, it will work,” he said during the briefing.
Dr. Park's study was sponsored by C.R. Bard Inc., maker of the EndoCinch kit.
EMILY BRANNAN, ILLUSTRATION