Endoscopic full-thickness plication (Plicator) with two serially placed implants improves esophagitis and reduces PPI use and esophageal acid exposure

Abstract

Recently, several endoluminal procedures for the treatment of gastroesophageal reflux disease (GERD) have been introduced. Most of these techniques have been abandoned because they lack long-term efficacy or have serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator was shown to be effective at controlling reflux symptoms and esophageal acid exposure. In all previous studies, only a single implant was used. The aim of the present pilot study was to determine the safety and efficacy of two serially placed Plicator implants. Thirty-seven patients requiring maintenance therapy with proton pump inhibitors (PPIs) were enrolled in this single-center pilot study. All patients received two Plicator implants. Exclusion criteria were hiatus hernia larger than 3 cm, grade IV esophagitis, Barrett's esophagus, and esophageal motility disorders. The primary study end point was at least 50 % improvement in the GERD Health-Related Quality of Life (HRQL) score. Secondary end points included GERD medication use, esophageal acid exposure, esophagitis grade, and heartburn/regurgitation scores. Thirty-seven patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months after treatment, the proportion of patients achieving at least 50 % improvement in GERD-HRQL score was 68 %. Complete cessation of PPI treatment was achieved in 59 % of patients. In pH studies conducted at 6 months (n = 29), median percentage of time for which pH was below 4 decreased by 36 %, with 28 % of patients experiencing pH normalization. There were no serious adverse events requiring intervention. Endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, medication use, and esophageal acid exposure.