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Endoscopic full-thickness fundoplication (EFTP) with a novel device significantly improved quality of life and severity of symptoms in gastroesophageal reflux disease (GERD) compared with a sham procedure, a randomized study in India found.

The single-center trial's primary endpoint of a 50% or greater improvement in health-related quality of life (GERD-HRQL) score at 3 months was achieved by 65.7% of patients in the EFTP group compared with 2.9% in the sham group (P<0.001), reported Rakesh Kalapala, MD, and colleagues at the Asian Institute of Gastroenterology in Hyderabad.

The endoluminal procedure using the GERDx device may be a good alternative to surgery in selected patients who want to discontinue long-term proton pump inhibitor (PPI) therapy. The benefits were observed in both the short and long term and may appeal to surgery-averse patients, the authors noted online in .

At 6 months, the median percentage improvement in GERD-HRQL was significantly higher in the EFTP group (81.4%, interquartile range [IQR] 60.9-100.0) compared with the sham group (8.0%, IQR 2.2-21.6; P<0.001). Similar improvement was seen at 12 months (92.3% [IQR 84.4-100.0] vs 9.1% [IQR 4.8-36.0], respectively; P<0.001).

Since most endoscopic GERD procedures are cumbersome, and robust long-term randomized data on efficacy are sparse, the investigators assessed this easy-to-use device in 70 PPI-dependent patients from October 2017 to April 2019.

Patients had classic GERD symptoms of heartburn and regurgitation and were randomized 1:1 to EFTP or a sham procedure. They had a median age of 36 (IQR 29-42), 71.4% were men, and 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). PPI dependence was greater in the sham arm.

The mean duration of the EFTP procedure was 17.4 (±4) minutes. Compared with other endoscopic anti-reflux procedures, the device's relatively short operating time could be a valuable feature. "Shorter operating time is one of the surrogate markers of the technical ease of the procedure," Kalapala and team wrote.

Secondary endpoints included overall improvement in reflux symptom scores, PPI usage, and esophageal acid exposure, as well as reflux episodes and endoscopic findings at 3, 6, and 12 months.

Notably, 62.8% of EFTP patients were off PPIs at 12 months compared with 11.4% of sham patients (P<0.001).

There was a slight improvement over baseline at 3 months in esophageal acid exposure as measured by 24-hour pH impedance monitoring in the EFTP group, but the difference was statistically non-significant. However, the number of total and non-acid reflux episodes experienced by patients decreased in the EFTP group compared with the sham group at 3 and 12 months.

"This suggests that clinical response to EFTP may be due to reduction in volume reflux as evident by a significant reduction in the total number of reflux episodes rather than normalization of acid exposure time," the investigators explained.

"This transoral device has comparable outcomes to those with invasive surgery provided the patients are selected after meticulous work-up," Kalapala told MedPage Today. "There are no major barriers to its use, but patients with large hiatus hernia or low-volume reflux GERD may not be ideal candidates for this endotherapy."

The study results align with that found a reduction in esophageal acid exposure but infrequent normalization of distal esophageal acid exposure by objective parameters. "Improvement in GERD-HRQL may be a more relevant and patient-centric goal as compared with normalization of esophageal acid exposure which is infrequent with the currently available devices," Kalapala's group wrote.

At 12 months, endoscopic esophagitis was observed in 0% of the EFTP group compared with 29.4% of the sham group; no major procedure-related adverse events occurred in either arm. In the EFTP group, one patient experienced left-sided chest pain requiring analgesics and another had left-sided pleural effusion with fever.

According to the authors, the cohort of patients likely to benefit from EFTP includes those with PPI dependence, abnormal acid reflux or non-acid reflux, and small hiatus hernia. They recommended that large prospective trials with long-term follow-up be conducted to assess the benefits of this procedure after 12 months.

Asked for his perspective on the findings, Arvind Trindade, MD, of Long Island Jewish Medical Center at Northwell Health in Hyde Park, New York, referred to a recent push to take patients off PPIs because of their association with adverse effects such as kidney injury.

"This well-done study is extremely promising and deserves further evaluation in larger cohorts with objective endpoints such as pH testing," Trindade, who was not involved in the research, told MedPage Today. "In addition, testing outside of tertiary centers is needed, and adoption in the United States would likely require additional studies here."

His center does not currently use GERDx technology, but has developed a new GERD management procedure called RAP (resection and plication).

Citing several limitations to their study, Kalapala and team noted its restriction to a single site and its small sample size. Additionally, initial screening and enrollment of patients were based on historical details, and PPI dependency was not confirmed objectively. Reflux could not be assessed objectively at the end of 12-month follow-up in all patients, with just 27 receiving 24-hour pH impedance monitoring.

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