A novel endoscopic full thickness plicator for the treatment of gastroesophageal reflux disease: a pilot study.
Chuttani, Ram; Sud, R.; Sachdev, Gopal; Puri, Rajesh; Kozarek, Richard; Haber, Gregory; Pleskow, Douglas; Zaman, Mohammed and Lembo, Tony (2002) A novel endoscopic full thickness plicator for the treatment of gastroesophageal reflux disease: a pilot study. Annual Meeting of American Society for Gastrointestinal Endoscopy Digestive Diseases Week San Francisco, May 2002.
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Gastroesophageal reflux disease (GERD) is a chronic disease and many patients require life- long therapy. Methods: A pilot study was performed in patients with symptomatic GERD in which a novel full-thickness plication within 1 cm of the gastroesophageal junction was placed. The primary end-points of the study were safety, feasibility and durability of the full- thickness plication. Secondary end-points were heartburn score, GERD medication use and 24 hour pH scores. Results: Full-thickness plication was successfully performed in 6 out of 7 patients with GERD requiring chronic proton pump inhibitor therapy with a mean procedure time of 21 minutes, suggesting the procedure was feasible. Mild epigastric pain was reported in 2 patients and difficulty with eructation in 1 patient; all symptoms resolved spontaneously within 7 days. Follow-up endoscopy at 6 months revealed an intac~ plication in all patients. Patients reported sustained reduction in heartburn scores (3, 6 and 12 months). One patient resumed use of a PPI during follow-up and ultimately underwent a laparoscopic Nissen fundoplication. Two patients were using H2 blockers or a prokinetic agent at least three times per week. Conclusions: Full-thickness plication is feasible, safe and appears to be long lasting. This is associated with a sustained reduction in symptoms and medication use for GERD.
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