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Author Notes:

Correspondence: G. A. Lehman, Division of Gastroenterology and Hepatology, Indiana University Medical Center, 550 N. University Boulevard, UH 4100, Indianapolis, IN 46202, USA; e-mail: glehman@iupui.edu.

Paul Fockens, Lawrence Cohen, Steven Edmundowicz, Kenneth Binmoeller, Richard Rothstein, Daniel Smith, Edward Lin, Nicholas Nickl, Bergein Overholt, Peter Kahrilas, Nimish Vakil, and Glen A. Lehman have no conflicts of interest or financial ties to disclose.

Subject:

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Surgery
  • Gastroesophageal reflux disease
  • Gatekeeper
  • GORD/GERD
  • Sham procedure
  • FULL-THICKNESS PLICATION
  • MULTICENTER TRIAL
  • FOLLOW-UP
  • GERD
  • IMPLANTATION
  • DEVICE
  • Gastroenterology

Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

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Journal Title:

Surgical Endoscopy

Volume:

Volume 24, Number 6

Publisher:

, Pages 1387-1397

Type of Work:

Article | Final Publisher PDF

Abstract:

Background: This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). Methods: A prospective, randomized, sham-controlled, single-blinded, international multicenter study planned final enrollment of 204 patients in three groups: up to 60 lead-in, 96 GK, and 48 sham patients. The sham patients were allowed to cross over to the GK treatment arm or exit the study at 6 months. The primary end points were (1) reduction in serious device- and procedure-related adverse device effects compared with a surgical composite complication rate and (2) reduction in heartburn symptoms 6 months after the GK procedure compared with the sham procedure. The secondary end point was improved esophageal pH (total time pH was<4) 6 months after the GK procedure compared with baseline. Results: A planned interim analysis was performed after 143 patients were enrolled (25 lead-in, 75 GK, and 43 sham patients), and the GK study was terminated early due to lack of compelling efficacy data. Four reported serious adverse events had occurred (2 perforations, 1 pulmonary infiltrate related to a perforation, and 1 severe chest pain) at termination of the study with no mortality or long-term sequelae. Heartburn symptoms had improved significantly at 6 months compared with baseline in the GK group (p<0.0001) and the sham group (p<0.0001), but no significant between-group difference in improvement was observed (p = 0.146). Esophageal acid exposure had improved significantly at 6 months compared with baseline in the GK group (p = 0.021) and the sham group (p = 0.003), but no significant between-group difference in improvement was observed (p = 0.27). Conclusions: The GK procedure was associated with some serious but infrequent complications. No statistically significant difference in outcomes was observed between the treatment and control groups at 6 months compared with baseline.

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© The Author(s) 2010.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License (http://creativecommons.org/licenses/by-nc/3.0/).

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