Transoral esophagogastric fundoplication can be an effective treatment for patients seeking to alleviate symptoms associated with gastroesophageal reflux disease, particularly in individuals with persistent regurgitation despite prior treatment with proton pump inhibitor therapy, according to the results of a new study published in the February issue of Gastroenterology (doi:10.1053/j.gastro.2014.10.009).
“Gastroesophageal reflux disease (GERD) remains one of the most common conditions for which Americans take daily medication, and PPI use has more than doubled in the last decade,” wrote lead authors Dr. John G. Hunter of Oregon Health & Science University in Portland, and Dr. Peter J. Kahrilas of Northwestern University in Chicago, and their associates. “Despite this, up to 40% of proton pump inhibitor (PPI)–dependent GERD patients have troublesome symptoms of GERD, despite PPI therapy.”
In the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication (RESPECT) trial, investigators screened 696 patients who were experiencing “troublesome regurgitation” despite daily PPI treatment. These subjects were evaluated via three validated GERD-specific symptom scales, and were either on or off PPI use at the time of trial commencement. Post trial, patients were blinded to therapy and were reassessed at intervals of 2, 12, and 26 weeks. All patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy at 66 months after the trial ended.
Regurgitation severity was based on the Montreal definition, which was used to measure efficacy of treatments given as part of the study. The Montreal definition of reflux is described by the authors as “either mucosal damage or troublesome symptoms attributable to reflux.” Those with “least troublesome” regurgitation while on PPIs “underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses.”
Eighty-seven subjects with GERD and hiatal hernias of at least 2 centimeters were randomly assigned to groups that underwent transoral fundoplication (TF) followed by placebo treatment after 6 months, while 42 subjects, who made up the control group, underwent a “sham surgery” and began regimens of once- or twice-daily omeprazole medication for 6 months.
Results showed that 67% of patients who received TF treatment experienced elimination of adverse regurgitation vs. 45% of those treated with PPI (P = .023). Control of esophageal pH also improved noticeably in patients who received TF treatment versus those who did not (9.3% vs. 6.3% on average, respectively, P < .001), but not in patients who received the “sham surgery” (8.6% preop vs. 8.9% postop on average). Fewer patients who received TF treatment recorded having “no response” after 3 months compared with those in the control group (11% vs. 36%, respectively, P = .004).
“Transoral fundoplication may fill the ‘therapeutic gap’ that exists between PPI and laparoscopic fundoplication,” wrote the authors. “Considering the virtual absence of dysphagia and bloating after TF, which may be problematic with LINX [LINX Reflux Management System], it would appear that TF is an option for patients with troublesome regurgitation, as well as for patients with troublesome GERD symptoms who wish not to take PPI over a protracted period of time.”
Several coauthors disclosed ties with the study sponsor EndoGastric Solutions of Redmond, Wash., as well as individual potential conflicts of interest.