Abstract
Background & Aims: 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 ≥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 ≥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.
| Original language | English |
|---|---|
| Pages (from-to) | 704-712 |
| Number of pages | 9 |
| Journal | Gastroenterology |
| Volume | 131 |
| Issue number | 3 |
| DOIs | |
| State | Published - Sep 2006 |
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All Science Journal Classification (ASJC) codes
- Gastroenterology
Cite this
Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease : A Randomized, Sham-Controlled Trial. / Rothstein, Richard; Filipi, Charles; Caca, Karel; Pruitt, Ronald; Mergener, Klaus; Torquati, Alfonso; Haber, Gregory; Chen, Yang; Chang, Kenneth; Wong, David; Deviere, Jacques; Pleskow, Douglas; Lightdale, Charles; Ades, Alain; Kozarek, Richard; Richards, William; Lembo, Anthony.
In: Gastroenterology, Vol. 131, No. 3, 09.2006, p. 704-712.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease
T2 - A Randomized, Sham-Controlled Trial
AU - Rothstein, Richard
AU - Filipi, Charles
AU - Caca, Karel
AU - Pruitt, Ronald
AU - Mergener, Klaus
AU - Torquati, Alfonso
AU - Haber, Gregory
AU - Chen, Yang
AU - Chang, Kenneth
AU - Wong, David
AU - Deviere, Jacques
AU - Pleskow, Douglas
AU - Lightdale, Charles
AU - Ades, Alain
AU - Kozarek, Richard
AU - Richards, William
AU - Lembo, Anthony
PY - 2006/9
Y1 - 2006/9
N2 - Background & Aims: 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 ≥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 ≥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.
AB - Background & Aims: 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 ≥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 ≥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.
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U2 - 10.1053/j.gastro.2006.07.004
DO - 10.1053/j.gastro.2006.07.004
M3 - Article
VL - 131
SP - 704
EP - 712
JO - Gastroenterology
JF - Gastroenterology
SN - 0016-5085
IS - 3
ER -