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Clinical Trials/NCT01410071
NCT01410071
Terminated
Not Applicable

Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction: Evaluation of the Differences Between Those Undergoing Endoscopic Therapy vs.Conservative Care

Wisconsin Center for Advanced Research1 site in 1 country153 target enrollmentSeptember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sphincter of Oddi Dysfunction
Sponsor
Wisconsin Center for Advanced Research
Enrollment
153
Locations
1
Primary Endpoint
symptom improvement
Status
Terminated
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
August 2009
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wisconsin Center for Advanced Research

Eligibility Criteria

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

Outcomes

Primary Outcomes

symptom improvement

Time Frame: one year

Secondary Outcomes

  • improved quality of life(one year)

Study Sites (1)

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