Gatekeeper Therapy: An Endoscopic Treatment for GERD: Randomized, Sham-Controlled Multi-Center Trial Overview

Gatekeeper Therapy: An Endoscopic Treatment for GERD: Randomized, Sham-Controlled Multi-Center Trial Overview Paul Fockens, Aaltje Lei, Steven Edmundowicz, Mike Lehmkuhl, Lawrence Cohen, Colleen D’Souza, Richard Rothstein, Carol Moriarty, Nicholas Nickl, Sylvia Nicholson, Bergein F. Overholt, Janet Miller, C.D. Smith, Vickie Swafford, Kenneth Binmoeller, Danielle Hauptman, Nimish Vakil, Ahmad Dalmar, Peter J. Kahrilas, Christine Ebert, Thomas Lee, Karen Hieston, Glen A. Lehman Background: The Gatekeeper Reflux Repair System (Medtronic, Shoreview, MN) is a promising endoscopic therapy that is designed to augment the functioning of the lower esophageal sphincter through the implantation of prostheses into the submucosal layer of the LES in an outpatient procedure. These prostheses, made of a biocompatible hydrogel material, expand upon contact with moisture, creating a mechanical barrier between the stomach and the esophagus, restricting the flow of gastric contents into the esophagus. Preliminary data from 68 patients in a European Multi-center study showed implantation of approximately 4 prostheses at the LES improved GERD symptoms in a majority of PPI dependent GERD patients. Aim: To evaluate the effects of the Gatekeeper Therapy in symptomatic GERD patients in a large, prospective, multi-center, randomized, sham-controlled study. Method: Recruitment is ongoing for a Multicenter U.S./European study. Inclusion criteria include: Symptomatic GERD with symptom control on PPI therapy. Baseline 24 hr with pH!Z4.0 ZO4% of time. Baseline GERDHRQLOZ20 off PPI. Exclusion criteria: Barrett’s O 2cm, strictures, varices, grade 3 or greater esophagitis, hiatal hernia O 3cm, prior anti-reflux surgery. Procedure: Implant 4 prostheses circumferentially in LES. 144 patients will be randomized by a sealed envelope at ratio of 2:1 implant vs. sham. Blind will be broken at 6 months, with sham patients offered Gatekeeper therapy. Outcome parameters being evaluated include HRQL, esophagitits, medication use, 24 hr pH, and implant persistence. Results: Enrollment started 09/24/03 with 210 subjects enrolled and 52 subjects randomized and implanted to date (12/01/04). Summary: The study is ongoing with enrollment completion anticipated by April, 2005. S1179 A Prospective Multicenter Trial on Ablation of Non-Neoplastic Barrett’s Epithelium by Endoscopic Argon Plasma Coagulation in Combination with Esomeprazole (APBANEX) Hendrik Manner, Andrea May, Stephan Miehlke, Walter Kraemer, Gabriele Niemann, Bernd Wigginghaus, Stephan Dertinger, Wolfgang Schimming, Ralf Kiesslich, Manfred Stolte, Christian Ell Background: In contrast to former clinical trials concerning the ablation of nonneoplastic Barrett’s epithelium (BE), Schulz et al. (Gastrointest Endosc, 2000) obtained a complete squamous regeneration after argon plasma coagulation (APC) in 98,6% of treated patients. The aim of this prospective study was to evaluate for the first time the effectiveness of APC at a high power setting for the ablation of BE in a multicenter trial. Methods: In 8 study centers, 60 patients (mean age 57, range 27-77; 47 male, 13 female) with endoscopic and histologically proven nonneoplastic BE (length of BE 1-8 cm) were recruited for treatment by APC in combination with esomeprazole. After baseline documentation by video endoscopy (VE) plus chromoendoscopy with 0,5% methylene blue (MB) and four quadrant biopsies (4QB) including the gastroesophageal transition zone, BE was treated by repeated APC using a power setting of 90 W; the number of APC sessions was restricted depending on the length of BE. During the treatment period, all patients received esomeprazole 80 mg daily; 2 weeks after completion of treatment the esomeprazole dose was reduced to 20 mg on demand daily or adapted to the result of 24 h pH monitoring. Endoscopic examinations including VE, chromoendoscopy with MB, and 4QB depending on pretreatment length of BE were performed 3 weeks, 6 and 12 months after completion of treatment. The effect of ablation was classified either as complete remission (CR; complete macroscopic and microscopic regression of BE), partial remission (macroscopic regression more than 50% depending on pretreatment length of BE) or minor response (macroscopic regression of BE less than 50%). Results: 51/60 recruited patients were treated within the study. 3 patients were lost for follow-up (FU) after complications had occurred. In 37 of 48 patients (77%) CR was achieved after a mean FU of 14 months (range 12-32). To achieve complete ablation of BE (mean length 3,6 cm), a mean of 2,6 APC sessions (range 1-5) were used. Transient complications (chest pain, fever) were noted in 9/51 patients (17,6%). Major complications (stricture formation, bleeding, perforation) occurred in 5/51 patients (9,8%). Conclusions: The fact that esophageal cancer incidence rate in non-neoplastic BE is low and the goal of ablation treatment namely complete ablation of BE is not reached in all patients together with the risk for morbidity due to ablation does not justify APC for ablation of non-neoplastic BE.