BOSTON -- An endoscopic surgical procedure to treat symptomatic gastroesophageal reflux disease (GERD) was safe and effective over a three-year follow-up, found researchers here.
BOSTON, Jan. 12 -- An endoscopic surgical procedure to treat symptomatic gastroesophageal reflux disease (GERD) was safe and effective over a three-year follow-up, found researchers here and at four other centers.
A full-thickness plication in the gastric cardia 1 cm below the gastroesophageal junction reduced the need for medication and improved quality of life, according to Douglas Pleskow, M.D., of Beth Israel Deaconess Medical Center, and colleagues.
Moreover, the improvements were stable from 12 months after the procedure to 36 months, Dr. Pleskow and colleagues reported online in Surgical Endoscopy.
The finding comes from a follow-up of a study conducted five years ago to test the efficacy and safety of endoscopic plication using a device called the Plicator, manufactured by NDO Surgical, Inc., of Mansfield, Mass.
The procedure restores the anti-reflux barrier, which Dr. Pleskow described in a statement as "a fold over the top part of the stomach that acts to prevent acid and other stomach contents from going up into the esophagus."
Restoring the barrier reduces the symptoms of GERD, he said.
After the one-year follow-up of the original study, the researchers at five centers were able to recruit 29 of the original 64 patients for a continued three-year follow-up, Dr. Pleskow said.
At the end of the initial study, he said, "59% of the patients who had had plication at one year (were) completely symptom-free."
"What the data shows now at three years," he added, "is that 55% of the original patient population had complete symptom relief."
Of the 29 patients in the follow-up, 28 were daily users of proton pump inhibitors to control their GERD symptoms before the surgery, and the remaining patient was using a histamine-2 receptor antagonist on a daily basis.
At the end of three years, the researchers reported, 16 of the 28 (or 57%) remained off daily proton pump inhibitor therapy. Two patients were on non-daily, on-demand proton pump inhibitor therapy, so that complete cessation was achieved in half the patients.
The patient who had been on baseline daily histamine-2 receptor antagonist therapy was not taking any anti-secretory therapy three years later, they said.
The researchers also found that median GERD-health related quality of life scores remained significantly improved at 36 months compared with baseline scores without medication. Specifically, the median score at baseline was eight on the 45-point scale, compared to 19 at three years, a change that was significant at P<0.001.
All of the adverse events seen in the study occurred immediately after surgery, and there were no new adverse events during the three-year follow-up.
The study was limited by the lack of a sham surgery group, Dr. Pleskow and colleagues said, although such a study is under way. Also, a referral bias may exist, because not all of the original 64 patients were included in the follow-up.
Also, they noted, the exclusion criteria for the study would have eliminated many of the patients encountered in clinical practice, including those with a large hiatal hernia, advanced erosive esophagitis, and non-response to anti-secretory therapy.