Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction

Terminated

• Conditions: Sphincter of Oddi Dysfunction; Abdominal Pain

• Registration Number: NCT01410071
• Lead Sponsor: Wisconsin Center for Advanced Research

Brief Summary

The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.

Detailed Description

Sphincter of Oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. Resting pressures \>40mm of Hg are considered abnormal. Individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. Sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. In most instances the pain is debilitating and could impair the quality of life. Endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. Data regarding the efficacy of such an approach are limited. A recent systematic review by the Cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of Oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Status Verified: 2011-08
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-03
• Last Update Submitted: 2011-08-03
• Study First Posted: 2011-08-04
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• over age 18
• suspected history and clinical features suggestive of sphincter of oddi dysfunction

Exclusion Criteria

• prior history of endoscopic therapy for sphincter of oddi dysfunction
• no proven sphincter of oddi dysfunction on manometry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptom improvement	one year

Secondary Outcome Measures

Name	Time	Method
improved quality of life	one year

Trial Locations

Locations (1)

Wisconsin Center for Advanced Research; 🇺🇸 Milwaukee, Wisconsin, United States