Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings

Condition(s) targeted: Lower Esophageal Ring; Dysphagia

Intervention: Bougie Dilation (Procedure); Needle-knife incision (Procedure)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
John Fang, M.D., Study Director, Affiliation: University of Utah HSC
James A DiSario, M.D., Principal Investigator, Affiliation: University of Utah HSC

The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. All patients will be followed for one year for recurrence and/or severity of dysphagia and will be placed on rabeprazole for that time period.

Official title: A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Recurrence at one year of Schatzki's ring

Secondary outcome:

GERD score at 1,3,6,9,12 month time intervals

Dysphagia score at 1,3,6,9,12 month time intervals

Detailed description: Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at endoscopy, the patient will be randomized to electrosurgical incision or standard bougie dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months).

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Between the ages of 18-80 with symptomatic Schatzki's ring

- No history of bleeding diathesis or other contraindication to bougie dilation or

electrosurgical incision

Exclusion Criteria:

- Contraindication to proton pump inhibitors

- Pregnancy

- Inability to provide informed consent

- History of previous esophagogastric surgery

- Presence of esophageal peptic stricture, esophageal motility disorder or esophageal

cancer that could otherwise account for dysphagia

- Nasopharyngeal lesion or nasal intubation intolerance causing inability to undergo

esophageal motility testing and ambulatory pH monitoring

University of Utah HSC, Salt Lake City, Utah 84132, United States

Starting date: August 2001
Ending date: December 2006
Last updated: December 23, 2007