A new study published in the journal Gut aimed to evaluate the efficacy and safety of a new, easy to use, endoscopic full-thickness fundoplication (EFTP) device in patients with gastroesophageal reflux disease (GERD).

This randomized, sham controlled trial allocated patients with proton pump inhibitor (PPI)-dependent GERD to EFTP or a sham procedure in 1:1 ratio. The trial’s primary endpoint was ≥50% improvement in health-related quality of life (GERD-HRQL) score at 3 months. The secondary end points were improvement in GERD-HRQL, PPI usage, reflux symptom scores, esophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. A total of 70 patients were randomized, with 35 patients in each group (median (IQR) age 36 (29-42) years).

• Around 70% of the patients had non-erosive reflux disease on endoscopy, with a mean DeMeester score of 18.9 (±19.93).
• The EFTP procedure took a mean (±SD) of 17.4 (±4) min.
• Patients in the EFTP group more commonly achieved the primary end point (65.7% vs 2.9%; p<0.001).
• Again, the EFTP group had significantly greater median (IQR) % improvement in GERD-HRQL at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001), and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months.
• About 62.8% patients in the EFTP group were not taking PPIs at 12 months, in comparison with 11.4% patients in the sham group (p<0.001).
• There was a partial improvement in pH-metry parameters 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).
• None of the patients in EFTP group had esophagitis on endoscopy, while 29.4% patients in the sham group had esophagitis at 12 months.
• There were no major procedure-related adverse events in any of the two groups.

EFTP using a novel device appears to be safe and effective at improving quality of life in patients with PPI-dependent, mostly non-erosive reflux disease, both at short and long terms.

Source: Kalapala R, Karyampudi A, Nabi Z, et al. Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial. Gut. 2022 Apr;71(4):686-694.