Transoral incisionless fundoplication provides durable control of chronic GERD symptoms, according to 3-year follow-up data from the TEMPO trial presented at the Society of American Gastrointestinal and Endoscopic Surgeons 2016 Annual Meeting.
“Our data demonstrate that the benefits of transoral incisionless fundoplication are sustained up to 3 years following the procedure,” Karim Trad, MD, clinical professor of surgery at George Washington University School of Medicine and Health Sciences, said in a press release. “Symptom control, reduction in acid exposure, healing of esophagitis, and cessation rates of [proton pump inhibitors] are maintained over time, proving that the TIF procedure is a durable alternative to PPIs and more invasive anti-reflux operations.”
Short-term safety and efficacy of TIF (EsophyX, EndoGastric Solutions) were demonstrated in previous trials with up to 12 months of follow-up. In the current study, Trad and colleagues evaluated the durability of these outcomes at 36 months in patients with chronic GERD who had small or absent hiatal hernias, troublesome symptoms despite at least 6 months of PPI therapy, and abnormal esophageal acid exposure.
Between June and August 2012, the research team randomly assigned 40 patients to undergo TIF and 23 to receive PPI therapy. At 6 months, the 21 remaining patients on PPI therapy elected to crossover to the TIF group. Several patients were lost to follow-up through the study period, leaving 34 original TIF patients with 3 years of follow-up and 18 crossover patients with 30 months of follow-up for the final analysis. Two of these patients underwent revisional laparoscopic procedures.
The researchers evaluated GERD symptoms with three validated measures and used esophagogastroduodenoscopy and 48-hour pH-metry for objective assessment.
Ninety-one percent of 43 patients reported their troublesome regurgitation was eliminated, 70% of 54 patients discontinued daily PPIs and 87% of 23 patients had healed reflux esophagitis at the end of follow-up.
Mean Reflux Symptom Index (RSI) scores and GERD Health-related Quality of Life scores improved after the procedure (P < .001 for both), and remained stable from 12 months through the end of follow-up (P > .05 for both). RSI scores were normalized in 87% of 46 patients.
The number of reflux episodes decreased from 172 ± 84 to 107 ± 71 (P < .001), and the mean percent total time pH less than four improved from 10.2% to 7.8% (P = .017).
The researchers concluded that these findings show TIF can provide durable control of chronic GERD symptoms, healing of esophagitis and improved esophageal acid exposure. – by Adam Leitenberger
Trad KS, et al. Abstract S007. Presented at: SAGES Annual Meeting; March 16-19, 2016. Boston.
Disclosure: Trad reports he received honoraria from EndoGastric Solutions. Please see the SAGES disclosures database for all other researchers’ relevant financial disclosures.