Volume 131, Issue 3, Pages (September 2006)

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Presentation transcript:

Volume 131, Issue 3, Pages 704-712 (September 2006) 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 Gastroenterology Volume 131, Issue 3, Pages 704-712 (September 2006) DOI: 10.1053/j.gastro.2006.07.004 Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 1 Study design. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 2 The Plicator system. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 3 The Plicator procedure. (A) Plicator retroflexed to gastroesophageal junction; tissue retractor advanced into gastric cardia. (B) Tissue withdrawn between Plicator arms. (C) Arms closed, transmural suture deployed. (D) Resulting full-thickness plication. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 4 Disposition of patients. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 5 GERD-HRQL score ≥50% improvement at 3 months ( ) off medications (intention to treat). aP value from Fisher exact test. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 6 GERD-HRQL scores (intention to treat). aP value from a paired t test. bP values for treatment comparisons are from an analysis of variance. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 7 PPI use (intention to treat). aP values for treatment comparison are from Fisher exact test. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions

Figure 8 Distal esophageal acid exposure. aP value from Wilcoxon signed rank test. bP value for treatment comparison from Wilcoxon rank sum test. Gastroenterology 2006 131, 704-712DOI: (10.1053/j.gastro.2006.07.004) Copyright © 2006 American Gastroenterological Association (AGA) Institute Terms and Conditions