Endoscopic full thickness fundoplication (EFTP) with use of a novel endoscopic plication device is effective for reducing gastroesophageal reflux disease (GERD) symptoms and improving the quality of life (QOL) in patients who are dependent on a proton pump inhibitor (PPI), according to a study in Gut.

The randomized, double-blinded, sham-controlled trial sought to determine the efficacy and safety of EFTP using the GERD-X device (G-SURG, Germany) in patients with PPI-dependent GERD compared with a sham procedure in improving health-related QOL (GERD-HRQL), GERD symptoms, and esophageal acid exposure.

The study was conducted at a gastroenterology institute in India from October 2017 to April 2019. The primary endpoint was a reduction of 50% or greater in GERD-HRQL total score at 3 months from baseline.


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A total of 70 patients were enrolled in the study (EFTP group, n=35; sham group, n=35). Participants had a median age of 36 (IQR, 29-42) years, and 71.4% were men. The mean duration of each procedure from gastroscope insertion to device removal was 17.4±4 minutes.

In the EFTP group, 65.7% of patients achieved 50% or greater improvement in the GERD-HRQL total score at 3 months postintervention vs 2.9% of patients (P <.001) in the sham group. At 12 months, no esophagitis was observed during endoscopy in all 18 EFTP patients, and in the sham group, 29.4% patients had grade A esophagitis.

Among EFTP participants, 62.8% were off PPIs at the end of the study compared with 11.4% of those in the sham group (P <.001).

The 24-hour pH impedance analysis at 3 months (EFTP=35; sham=35) and 12 months (EFTP=27; sham=9) postintervention showed that the EFTP group had a decrease in esophageal acid exposure (median percentage time with pH <4 in 24 hours) from baseline, although the difference was not significant.

The median number of nonacid reflux episodes in 24 hours was significantly lower in the EFTP group vs the sham group at 3 months (P =.048) and 12 months (P =.005) postintervention. No major procedure-related adverse events were reported.

The investigators noted that their study was conducted at a single center and included a small sample size. In addition, initial screening and enrollment of patients were based on historical details, and PPI dependency was not confirmed objectively. Further, reflux was not assessed objectively at the end of the 12-month follow-up in all patients.

“This endoluminal procedure is a promising alternative option to surgery in an appropriately selected group of patients, who may not want to continue PPI long term,” the researchers commented. “A preferred cohort of patients who would benefit from EFTP includes those with PPI dependence, abnormal acid or nonacid 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.”

Reference

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;71(4):686-694. doi:10.1136/gutjnl-2020-321811