235 5-YEAR FOLLOW-UP OF A PROSPECTIVE CLINICAL TRIAL OF AN ENDOSCOPIC FULL-THICKNESS PLICATION DEVICE (GERDX™) FOR THE TREATMENT OF GERD

Abstract

Abstract The gold-standard in the operative treatment of gastroesophageal reflux disease (GERD) is the laparoscopic fundoplication. Alternatively, endoscopic devices to rebuild the gastroesophageal valve were invented. The aim of our study is to assess the improvement of GERD symptoms and quality of life in patients five years after the endoscopic full-thickness plication with the GERDx™ device. Methods Between 2013 and 2016 a prospective trial was implemented with forty patients and an endoscopic plication due to reflux symptoms with a pathologic workup for GERD. Limitation for the use of GERDx™ was a 2 cm hiatal hernia. Follow-up workup was done with high resolution manometry (HRM), 24 h-pH-impedance-catheter gastroscopy and questionaires for quality of life (GIQLI) and reflux-symptoms (SCL). Results Median follow-up time was 57 months (36–74 months). There was a significant improvement of the DeMeester score, GIQLI and SCL between pre- and postoperative values in short-term as well as long-term follow-up. At least 55% of patients were assessed as failure of the plication device due to redo operations with laparoscopic fundoplication in 25% and/or necessary PPI use for GERD symptoms (40%). There is no pre- and postoperative significant difference in quality of life or reflux scores between successful and failed endoplications, but patients with laparoscopic redo operations showed significant higher DeMeester scores before and after endoscopic treatment. Conclusion There is a higher failure rate to the endoscopic full-thickness plication than to the laparoscopic fundoplication. A small group of well selected patients is eligible for the endoscopic GERDx™ device. In case of therapeutic failure a classic laparoscopic redo fundoplication is possible under more challenging operative conditions.