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

NCT ID: NCT01410071

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-08-31

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.

Conditions

Sphincter of Oddi Dysfunction; Abdominal Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

sphincter of oddi dysfunction

endoscopic therapy vs conservative care

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

Wisconsin Center for Advanced Research

OTHER

Sponsor Role: lead

Responsible Party

Wisconsin Center for Advanced Research, Division of GI Associates LLC

Principal Investigators

Nalini M Guda, MD

Role: PRINCIPAL_INVESTIGATOR

GI Associates

Locations

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

S-05-130E

Identifier Type: -

Identifier Source: org_study_id