A Prospective Multicenter Phase II Study to Evaluate Endocynch Suturing System for the Treatment of GERD

A Prospective Multicenter Phase II Study to Evaluate Endocynch Suturing System for the Treatment of GERD Thierry Ponchon, Jean Boyer, Jean Charles Grimaud, Jean-Christophe Letard, Jean Escourrou, Frederick Ducrot, Jean Marc Canard, Jean Francois Rey, Group Sfed Only one multicenter prospective study has been published so far on the feasibility of endoscopic suturing for the treatment ofGERD.A newmulticenter prospective study on efficacy and safety of the procedure was conducted. Patients (pts) and methods: Inclusion criteria were: age>18y, symptomatic GERD (GERDHRQL>20 without treatment), continuous and effective PPI therapy for more than 3months, absence of hiatal hernia, Barrett’s or achalasia, bodymass index< 40. During the 2 months prior the procedure, GERD-HRQL score, esophageal 24h pHmetry and manometry were obtained once PPI were stopped for 10 days. 2 or 4 sutures (Endocynch, Bard) were performed on a vertical axis, the upper at the level of the Z line. Follow-up consisted in: questionnaire at 1,3,6 and 12 months (mo), pHmetry, manometry and gastroscopy at 3 mo, gastroscopy at 1 year. Results: 60 pts (mean age: 49, 20 females) were included. Amean of 2.7 sutures per pt was used. Side-effects rapidly resolutive were: retrosternal pain (15%) and dysphagia (18%). The percentage of pts without PPI is 75% at 1mo, 67% at 3 mo, 53% at 6 mo and 50% at 12 mo. The percentage of pts still with PPI but at lower doses is 19%at 1mo, 25%at 3mo, 28%at 6moand 33%at 12mo.GERD-HRQL decreased at 1, 3, 6 and 12mo (p<0.05).Only one pt had surgery during the followup period. Lower esophagus sphincter pressure was unchanged at 3 mo. pH<4 time was reduced from 11.2 to 9.2% at 3 months (p<0.05). At gastroscopy, all initial sutures were in place in 48% of pts, and at least one suture has disappeared in 52% of cases (including 4% of pts without any more suture). Conclusion: This study demonstrates the safety of this suturing system for the treatment of GERD and its efficacy to reduce the need for PPI treatment. However, gastroscopy and results observed at 1 year suggest that long term persisting effects are uncertain. performedwith a 20MHzUS transducer and awater perfusedmanometry catheter in 8 patients with GERD before and after endoscopic plication. US images and manometric pressure tracingswere synchronized using a kayelemetrics swallowing workstation. The catheter assembly was placed in the stomach and withdrawn through the gastroesophageal junction high pressure zone (GEJHPZ) at a constant velocity of 0.5 cm/sec during breath holding. US images were analyzed for the configuration of the plications, depth of sutures, location of the plications with respect to the CD and changes in the pressure profile. 3D reconstruction of the US images was performed. Results: The plications appear as hypoechoic round structures on 2D US and hypoechoic spherical structures on 3D US. The sutures appear as hyperechoic lines within the plications. The majority of sutures are localized to the submucosa. The majority of the plications were located at or just below theRightCrus of the diaphragm.The distal portion of the pressure profile in theGEJHPZwas lengthened in the area of the plications. Conclusions: 2D and 3D US with simultaneous manometry can be used to localize endoscopic plications, depth of sutures, and changes in the pressure profile pre-and post-Endocinch. Funded through an NIH grant R01 DK59500-03 and C.R. Bard Inc. grant.