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




Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Journal Title:

Surgical Endoscopy

Volume:

Volume 24, Number 6

Publisher:

Springer Verlag Germany | 2010-06-01, 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.

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



Autor: Paul Fockens, Lawrence Cohen, Steven A. Edmundowicz, Kenneth Binmoeller, Richard I. Rothstein, Daniel Smith, Edward Lin, Nicholas

Fuente: https://open.library.emory.edu/



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