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NCT01410071 Clinical Trial

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

Abdominal Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01410071
Other study ID # S-05-130E
Secondary ID
Status Terminated
Phase N/A
First received August 2, 2011
Last updated August 3, 2011
Start date September 2005
Est. completion date August 2009

Study information
Verified date August 2011
Source Wisconsin Center for Advanced Research
Contact n/a
Is FDA regulated No
Health authority USA: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 153
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Wisconsin Center for Advanced Research Milwaukee Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Wisconsin Center for Advanced Research Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary symptom improvement one year No
Secondary improved quality of life one year No
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