Endoscopic full-thickness fundoplication improves quality of life in PPI-dependent GERD
Endoscopic full-thickness fundoplication was safe and effective for the improvement of quality of life in patients with proton pump inhibitor-dependent gastroesophageal reflux disease, according to a study published in Gut.
“This endoluminal procedure is a promising alternative option to surgery in appropriately selected group of patients, who may not want to continue PPI long term,” Rakesh Kalapala, MD, from the Asian Institute of Gastroenterology in Hyderabad, India, and colleagues wrote. “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 1year.”
Kalapala and colleagues randomly assigned 70 patients with PPI-dependent GERD to either endoscopic full-thickness fundoplication (EFTP) or to a sham procedure. Fifty percent or more improvement in the health-related quality of life (GERD-HRQL) score at 3 months served as the primary endpoint. Other endpoints included improvement in GERD-HRQL, reflux symptom scores, PPI use, esophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months.
Investigators noted 70% of patients had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9. The EFTP procedure lasted a mean of 17.4 minutes.
“The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; P < .001),” Kapala and colleagues wrote. “Median (IQR) [percent] improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 [60.9–100] versus 8 (2.2–21.6; P < .001) and 12 (92.3 [84.4–100] versus 9.1 (4.8–36); P < .001) months.”
According to researchers, 62.8% of patients were off-PPI at 12 months in the EFTP group vs. 11.4% in the sham group (P < .001). At 3 months, pH-metry parameters partially improved (n = 70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs. sham); however, not at 12 months (n = 27). In addition, endoscopic esophagitis was seen in 0% of the treatment group (n = 18) at 12 months; however, there were five in the control group (n = 17). There were no adverse events observed in either group.