In patients with gastroesophageal reflux disease (GERD) who are dependent on proton-pump inhibitors (PPI), endoscopic full-thickness fundoplication (EFTP) using a novel device significantly improved GERD-related quality of life and severity of reflux symptoms in a randomized, sham-controlled clinical trial conducted in India. This endoluminal procedure using the GERD-X device (G-SURG, Germany) has a "short operating time and very few side effects (and) is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long-term," Dr. Rakesh Kalapala of the Asian Institute of Gastroenterology in Hyderabad and colleagues write in the journal Gut. The study enrolled 70 adults (median age, 36; 71% men) with classic reflux symptom (heartburn, regurgitation) who were dependent on PPI therapy for at least six months; 35 were randomly allocated to the EFTP procedure using GERD-X and 35 to a sham procedure. On endoscopy, 70% of patients had non-erosive reflux disease. The primary endpoint - 50% or more improvement in the health-related quality of life (GERD-HRQL) score at three months - was more often achieved in the EFTP group (65.7% vs. 2.9%; P<0.001), the authors report. The median percent improvement in GERD-HRQL was significantly higher in the EFTP group at six months (81.4% vs. 8.0%; P<0.001) and 12 months (92.3% vs. 9.1%; P<0.001). Two-thirds (62.8%) of patients in the EFTP group were off PPI therapy at 12 months versus 11.4% in the sham group (P<0.001). EFTP was associated with partial improvement in pH-metry parameters at three but not 12 months. Endoscopic esophagitis was present in none of the 18 EFTP patients evaluated at 12 months, compared with five of 17 (29.4%) patients in the control group. "No major procedure-related adverse events were observed in either group," the authors report. They note that the average duration of the EFTP procedure was 17.4 minutes. "As compared with other endoscopic antireflux procedures, a relatively short operating time could be a valuable feature of this novel EFTP device. Shorter operating time is one of the surrogate markers of the technical ease of the procedure," Dr. Kalapala and team write in their report. The say the "preferred cohort of patients who would benefit from EFTP includes those with PPI dependence, abnormal acid or non-acid reflux and small hiatus hernia. The procedure is short and with very few side effects. Large, prospective trials with long-term follow-up are required to conclude the benefits of this procedure after 1 year." The study had no specific funding and the authors have no relevant disclosures. —Reuters Staff Source
