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

2005; Elsevier BV; Volume: 61; Issue: 5 Linguagem: Inglês

10.1016/s0016-5107(05)00794-7

1097-6779

Paul Fockens, Aaltje Lei, Steven A. Edmundowicz, Mike Lehmkuhl, Lawrence B. Cohen, Colleen D'Souza, Richard Rothstein, Carol Moriarty, Nicholas Nickl, Sylvia Nicholson, Bergein F. Overholt, Janet C. Miller, C. D. Smith, Vickie Swafford, Kenneth F. Binmoeller, Danielle Hauptman, Nimish Vakil, Ahmad Dalmar, Peter J. Kahrilas, Christine C. Ebert, Thomas Lee, Karen Hieston, Glen A. Lehman,

Esophageal Cancer Research and Treatment

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<=4.0 =>4% of time. Baseline GERD-HRQL >=20 off PPI. Exclusion criteria: Barrett's > 2cm, strictures, varices, grade 3 or greater esophagitis, hiatal hernia > 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.