In patients with proton pump inhibitor (PPI), dependent gastroesophageal reflux disease (GERD), a procedure known as full-thickness endoscopic application (EFTP) – performed with the new GERD-X device – improved symptoms and quality of life, compared to a simulated procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial.
“It seems like a quick and easy procedure to use,” Gyanprakash A. Ketwaroo, MD, Master, who is an assistant professor of medicine at Baylor College of Medicine, Houston, commented in an interview. Ketwaroo did not participate in the study.
“While the objective measures were not as good as you might have expected, the subjective results were good. [And] it appears that it may have more long-term advantages compared to some of the other endoscopic procedures. But that was not one [primary] result of the study, and we still need more long-term studies to find out, ”he added.
The fact that the TVET procedure is relatively simple could reduce costs and facilitate the learning curve, which in turn could expand accessibility if more gastroenterologists are trained.
“Not many gastroenterologists offer endoscopic approaches to GERD therapy, so this cohort increases [could] they potentially have a big impact given the number of patients who have GERD in this country, and especially given the growing and persistent concern about long-term use of PPIs, ”Ketwaroo said.
Addressing the disadvantages of long-term PPI use
Although PPIs are the most effective medical therapy for GERD, there is concern that long-term use may increase the risk of acute and disease conditions. chronic kidney disease, hypomagnesemia, Clostridioides difficult infection and osteoporotic fractures. Antireflux surgeries are effective, but they can cause them dysphagia, infloresc i diarrhea.
EFTP applies transmural sutures to the gastroesophageal junction to strengthen the valvular mechanism, which reduces reflux. Although the preponderance of published tests supports the Esophyx device (EndoGastric Solutions), which has an efficiency index of 70% and few adverse events in a analysis, requires advanced training and general anesthesia and takes 45-100 minutes.
“Endoscopic fundoplication is a minimally invasive antireflux therapy in PPI-dependent patients who reject surgery; however, most endoscopic devices are cumbersome to use and lack robust data on their long-term efficacy,” he said. pointed out Kalapala and his paper colleagues.
In 2014, the German company G-Surg introduced a new endoscopic plication device called GERD-X. A potential, one-armed to study had demonstrated efficacy in both patients taking PPI and those with refractory GERD.
A closer look at the device
To strengthen this evidence, Kalapala and colleagues conducted this new monocentric, randomized, and simulated trial, with 70 enrolled with PPI-dependent GERD, of whom 70% had non-erosive reflux disease (mean score). of DeMeester, 18.9). The mean age of the participant was 36 years and 71.4% were male. The average procedure time was 17.4 minutes.
Of the subjects in the treatment group, 65.7% achieved a 50% improvement in health-related quality of life (GERD-HRQL) after 3 months, compared with 2.9% in the simulated group (Pg <.001). The mean percentage improvement in GERD-HRQL score was higher in the 6-month treatment group (81.4% vs. 8.0%; Pg <.001) and at 12 months (92.3% vs. 9.1%; Pg <.001). Similar improvements were observed at 6 and 12 months in the score for stomach acidity symptoms (75.0% vs. 13.0% and 89.7% vs. 15.4%, respectively; Pg <.001 for both) and regurgitation symptom score (96.2% vs. 6.9% and 100% vs. 3.4%, respectively; Pg <.001 for both). At 12 months, 62.8% of the treatment group no longer took PPI, compared with 11.4% of the simulated group (Pg <.001).
Objective improvement measures were more modest. The treatment arm tended toward a reduction in esophageal acid exposure from baseline at 3 and 12 months, but the difference was not statistically significant. The mean percentage of time with esophageal pH less than 4 and the DeMeester score were similar between the groups at 3 and 12 months. The researchers also observed trends toward fewer reflux events in 24 hours in the treatment group at 6 months (Pg = .072) and 12 months (Pg = 0.051).
The treatment group had fewer episodes of non-acid reflux at 12 months than the baseline value (Pg = 0.038), but there were no differences in the mean number of acid reflux episodes in 24 hours.
“Our study found that full-thickness endoscopic fundoplication, using a new device, was safe and significantly improved the quality of life related to GERD and the severity of short- and long-term reflux symptoms, compared with a simulated procedure, “the authors wrote.
“This endoluminal procedure with a short operating time and very few side effects is a promising alternative option to surgery in a properly selected group of patients, who may not want to continue with long-term PPI,” they concluded.
The study authors did not disclose any external funding. Ketwaroo has no relevant financial disclosures, although he is part of the editorial advisory board of GI & Hepatology News.
This article was last updated on May 6, 2021.
This article originally appeared on MDedge.com, which is part of the Medscape professional network.