Effective Endoscopic Treatment of Gastroesophageal Reflux Disease Using a New Endoscopic Stapling System Results of a Prospective Controlled Multicenter Trial.
INTRODUCTION: The aim of this prospective multicenter controlled study was to test the safety and efficacy of a new system which is designed for trans-oral endoscopic treatment of Gastro Esophageal Reflux Disease (GERD). The device is a flexible video endoscope coupled with a surgical stapler and an ultrasonic range finder. Using this device, the operator can staple the fundus of the stomach to the esophagus, about 3cm above the GE junction, using 2 or 3 quintuplets of staggered standard 4.8mm surgical staples. The result of the stapling is anatomically equivalent to anterior fundoplication.
METHODS: Inclusion criteria: moderate to severe GERD with response to PPI treatment, abnormal 24h esophageal acid exposure and Hill gastro-esophageal valve grade ≥2. Patients with significant comorbidities, esophageal motility disorders and hiatal hernia > 3 cm were excluded. Procedures were performed under general anesthesia at 6 centers using positive end expiratory pressure (PEEP) to reduce the hernia, if present. Anterior fundoplication was performed with two or three stapling sites between the esophagus and the stomach under control of the ultrasonic range finder. Patients were followed at 1, 2 and 4 weeks for safety and at 6 months for efficacy. The primary outcome of the study was safety and reduction of the off-PPI GERD Health Related Quality of Life scores (GERD-HRQL) score by at least 50%. Secondary outcome criteria were elimination or reduction of daily PPI use, improvement in 24h acid exposure and of Hill valve grade.
RESULTS: 69 patients were treated as per protocol. Primary outcome - Safety: There were 2 occult perforations (one transient pneumomediastinum, and one resulting in empyema – treated by chest tube drainage) and one case of bleeding requiting transfusion. All device-related serious adverse events occurred in the first 24 subjects. After refining the technique, none were observed. Other adverse events were mild and transitory. Primary outcome - Efficacy: 3 subjects were excluded due to major protocol violations, and 64 completed the follow up. 75% patients (48/64) met the primary success criterion – 50% reduction in GERD-HRQL scores. The median GERD-HRQL scores dropped from baseline of 29 to 6 at six months post-procedure (p<0.001). Median acid exposure (percent of time pH<4) dropped from 8.30% (4.7-73.9%) at baseline (mean 11.05±10.8) to a value of 6.75 (0-21.0) (mean of 7.30±5.12) six months following the procedure (p=0.002). Eighty five percent of the 66 patients reduced daily PPI use by 50% or more. Seventy seven percent (of 60 patients with follow up endoscopy) demonstrated an improved flap valve angle at 6 months.
CONCLUSIONS: This study shows that the Medigus SRSTM Endoscopic stapling device is a safe and effective endoscopic treatment for GERD patients with a sliding hiatal hernia of up to 3cm. The procedure under general anesthesia showed acceptable complications rate, high efficacy rates (75%) and can be recommended for patients with up to 3 cm sliding hiatal hernia.