Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial.
OBJECTIVE
The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure.


METHODS
Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure.


RESULTS
By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths.


CONCLUSIONS
Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.
Rothstein
Richard
R
Section of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA. richard.i.rothstein@dartmouth.edu
Filipi
Charles
C
Caca
Karel
K
Pruitt
Ronald
R
Mergener
Klaus
K
Torquati
Alfonso
A
Haber
Gregory
G
Chen
Yang
Y
Chang
Kenneth
K
Wong
David
D
Deviere
Jacques
J
Pleskow
Douglas
D
Lightdale
Charles
C
Ades
Alain
A
Kozarek
Richard
R
Richards
William
W
Lembo
Anthony
A
D016099:Endoscopy, Gastrointestinal; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000295:instrumentation*; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000378:metabolism / Q000523:psychology / Q000601:surgery*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome