Esophagus to Small Intestine
Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: Results from a randomized, sham-controlled trial
Background: The majority of endoscopic antireflux procedures for gastroesophageal reflux disease (GERD) are cumbersome to use and randomized long-term data are sparse. The authors conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD.
Design: Patients with proton-pump inhibitor (PPI)-dependent GERD were randomized to either EFTP or a sham procedure in 1:1 ratio. The primary end point was ≥ 50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, esophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months.
Results: 70 patients were randomized; 35 in each group with a median (interquartile range, IQR) age of 36 (29–42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (± 19.93). The mean (± SD) duration of EFTP procedure was 17.4 (± 4) minutes. The primary end point was more frequently achieved in the EFTP group (65.7% vs. 2.9%; p < 0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 [60.9–100.0] vs. 8.0 [2.2–21.6]; p < 0.001) and 12 (92.3 [84.4–100.0] vs. 9.1 [4.8–36.0]; p < 0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p < 0.001). pH-metry parameters partially improved at 3 months (n = 70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs. sham) but not at 12 months (n = 27); endoscopic esophagitis was seen in 0% in the treatment (n = 18) and 5 (29.4%) in the control group (n = 17) at 12 months. No major procedure-related adverse events were encountered in either group.
Conclusion: Endoscopic full-thickness fundoplication using a novel device is safe and effective in improving quality of life in patients with proton-pump inhibitor-dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate.