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Introduction: A new system which is designed for transoral endoscopic treatment of Gastro Esophageal Reflux Disease (GERD)was tested in a multicenter study. The device is a flexible video endoscope coupled with a surgical stapler and an ultrasonic range finder. The device can endoscopically create an anterior fundoplication. Aim of the current prospective controlled multicenter trial was to evaluate safety and efficiency of the newly developed endoscopic stapling device in GERD patients with small hernias. Methods: Inclusion criteria moderate to severe GERD with response to PPI treatment, abnormal 24h esophageal acid exposure and Hill gastro-esophageal valve grade ≥II. Patients with significant comorbidities, esophageal motility disorders and hiatal hernia > 3 cm were excluded. Procedures were performed under general anesthesia at 5 centers using positive end expiratory pressure (PEEP) to optimum reduction of the hernia. 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 PPI use, improvement in 24h acid exposure and Hill valve grade.
Results: 67 patients were finally treated as per protocol. Primary outcome - Safety: There were 2 occult perforations (pneumomediastinum - asymptomatic and empyema - chest tube drainage) and one case of bleeding (treated endoscopically). Hospital stay was prolonged in another patient due to signs of infection. Additional adverse events occurred in 12 patients, were mostly related to elevated inflammatory markers in the first 24-48h post procedure and did not appear to carry any clinical significance. They were more common when only two rather than three staplings had been placed.
Primary outcome - Efficacy: 74% patients (50/67) met the primary success criterion - 50% reduction in GERD-HRQL scores. The median scores drooped from baseline of 29 to 6 at six months post-procedure (p<0.001). Acid exposure normalized in 49% (33/67) subjects and improved in additional 18% (12/67). PPI usage reduced by ≥ 50% in 85% (57/67) patients (p<0.001,. 73% patients (46/63) demonstrated an improved flap valve angle at 6 months.
Conclusions: This study shows for the first time an effective endoscopic treatment for GERD patients. The new developed Medigus stapling device can endoscopically create an anterior fundoplication. The procedure under general anesthesia showed acceptable complications (6%), high efficacy rates (74%) and can be recommended for patients with small hernias.