Endoscopic Stapling System for Trans Oral Treatment of GERD - Three Years Follow Up

Roy-Shapira and Bapaye
Presented at DDW 2011
INTRODUCTION: Between May and October 2007, an IRB approved, pilot study of a new endoscopic stapling device for the treatment of GERD was conducted on 13 subjects in Pune, India. Subjects with history of PPI use > 2y for GERD and no co-morbidity were included. The device is a modified gastroscope, which includes a surgical stapler, that fires a staggered quintuplet of standard titanium B shaped 4.8mm staples, and an ultrasonic range finder. All procedures were done under general anesthesia by a single operator. Either 2 or 3 staple quintuplets were used to staple the fundus to the esophagus,creating a 90-180 degree anterior fundoplication over the distal 2-3cm of the esophagus. This is a report of the results of a three year follow up on this group of subjects
METHODS: The original Informed consent specified that the subjects may be contacted annually for 5 years following the study. Accordingly subjects were contacted for a telephone interview during the first week of October 2010. The following data were collected: Velanovich GERD-HRQL scores, PPI use, symptoms, satisfaction with the procedure, and wllingness to repeat the procedure again.
RESULTS: 11 of the 13 subjects could be reached by phone. GERD-HRQL scores were less than 9 or less in 10 subjects and 15 in one subject, The latter subject improved his score from 29 to 15, in all others score improved by more than 50%. All subjects would have agreed to do the procedure again. Mean satisfaction score was 7.7 (6-10) on a scale of 1-10. There was no dysphagia. Three subjects resumed PPI intake, (compared to 2 at the 2y follow up) 3 subjects require PPI at a reduced dose 1 subjects takes PPI only after a large meal and 4 subjects remained completely off PPI
CONCLUSION: At 3 years, the procedure remained effective in improving the quality of life in moderate to severe GERD without causing dysphagia. PPI use was eliminated or reduced in 73% of subjects. All subjects remain satisfied with the procedure and would do it all over again. Further studies are necessary to validate these data and determine optimal staple placement.