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4469 Transoral endoscopic suturing for gastroesophageal reflux disease: a multicenter trial.

2000; Elsevier BV; Volume: 51; Issue: 4 Linguagem: Inglês

10.1016/s0016-5107(00)14316-0

1097-6779

Charles J. Filipi, Steven A. Edmundowicz, Christopher J. Gostout, Glen A. Lehman, Isaac Raijman, Richard Rothstein, GREG VAN STIEGMAN, Patrick J. Waring, Sharon A. Sweeney, Ken Dieselman, Donal Dunne,

Gastrointestinal disorders and treatments

Louis, MO; Mayo Clin, Rochester, MN; Indiana Univ, Indianapolis, IN; Park Plaza Med Ctr, Houston, TX; Dartmouth Hitchcock Med Ctr, Lebanon, NH; Colorado Univ, Denver, CO; Emory Univ, Atlanta, GA; C R BAAD, Inc, IN. Introduction: A totally transoral outpatient procedure for the treatment of gastroesophageal reflux disease (GERD) would be appealing to physicians and patients. Methods: A multicenter trial was initiated for 64 patients suffering from symptomatic GERD. Inclusion criteria were 3 or more heartburn episodes per week while off medication, dependency on antisecretory medicine and documented acid reflux by pH monitoring (pH < 4 for more than 4% of the total monitoring time). Exclusion criteria were age < 18, pregnancy, dysphagia, grade 3-4 esophagitis, obesity (BMI>40kg/ meter2) previous esophageal surgery and hiatus hernia >2 cm. Patients underwent esophageal manometry, endoscopy, 24 hour pH monitoring and completed a MOS SF-36 quality of life (QOL) questionnaire and symptom severity scoring. Patients were then randomized to a linear or circumferential plication configuration group. After the endoscopic valvuloplasty patients repeated the (QOL) questionnaire and underwent endoscopy, manometry and 24 hour pH monitoring at 3 months and 6 months. All adverse procedural events were recorded. Symptom change scores were analyzed with the Wilcoxon signed-rank test. Procedural success was defined as patients that were symptom free with fewer than 4 doses of acid reduction medicine per month. Results: Sixty-two percent of patients experienced success at 3 months. Six month data are pending. Mean three month symptom change scores demonstrated procedural efficacy. GROUP MEAN VALUES Baseline, 3 months p (sign rank test): Heartburn score 62.5, 16.6, 0.0001, Heartburn frequency 2.8, 1.4, 0.0001, Heartburn severity 22.8, 9.2, 0.0001, Regurgitation 1.8, 0.6, 0.0001 respectively, Of those patients suffering with regurgitation (80%), more than one half (55%) reported they no longer suffer from this problem. Only patients with preprocedure acid reflux time >10% had an improvement in % time pH < 4 (p=0.002). QOL data are yet to be analyzed. Plication configuration and number did not effect symptom improvement. One patient had a suture perforation of the distal esophagus that was successfully treated with antibiotics. Two patients experienced mucosal tears secondary to an overtube. No intervention was required and no symptoms resulted. Four patients experienced hypoxia during the procedure, one of which required a general anesthetic for a second procedure. All patients recovered without sequelae. Conclusion: Endoscopic valvuloplasty has minimal morbidity and is successful in controlling most symptoms at 3 month follow-up.