Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease

A Randomized, Sham-Controlled Trial

Richard Rothstein, Charles Filipi, Karel Caca, Ronald Pruitt, Klaus Mergener, Alfonso Torquati, Gregory Haber, Yang Chen, Kenneth Chang, David Wong, Jacques Deviere, Douglas Pleskow, Charles Lightdale, Alain Ades, Richard Kozarek, William Richards, Anthony Lembo

    Research output: Contribution to journalArticle

    100 Citations (Scopus)

    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 languageEnglish (US)
    Pages (from-to)704-712
    Number of pages9
    JournalGastroenterology
    Volume131
    Issue number3
    DOIs
    StatePublished - Jan 1 2006

    Fingerprint

    Gastroesophageal Reflux
    Randomized Controlled Trials
    Proton Pump Inhibitors
    Intention to Treat Analysis
    Quality of Life
    Therapeutics
    Cardia
    Acids
    Sutures
    Multicenter Studies
    Stomach
    Maintenance

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • 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, 01.01.2006, p. 704-712.

    Research output: Contribution to journalArticle

    Rothstein, R, Filipi, C, Caca, K, Pruitt, R, Mergener, K, Torquati, A, Haber, G, Chen, Y, Chang, K, Wong, D, Deviere, J, Pleskow, D, Lightdale, C, Ades, A, Kozarek, R, Richards, W & Lembo, A 2006, 'Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial', Gastroenterology, vol. 131, no. 3, pp. 704-712. https://doi.org/10.1053/j.gastro.2006.07.004
    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. / Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease : A Randomized, Sham-Controlled Trial. In: Gastroenterology. 2006 ; Vol. 131, No. 3. pp. 704-712.
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    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.",
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    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

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    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.

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