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

This study has been terminated.
(Analysis of designed comparison groups not viable)
Sponsor:
Collaborator:
Aurora Health Care
Information provided by:
Wisconsin Center for Advanced Research
ClinicalTrials.gov Identifier:
NCT01410071
First received: August 2, 2011
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition
Sphincter of Oddi Dysfunction
Abdominal Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Wisconsin Center for Advanced Research:

Primary Outcome Measures:
  • symptom improvement [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improved quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: September 2005
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
sphincter of oddi dysfunction
endoscopic therapy vs conservative care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

physician's private practice/clinic patients presenting with suspected sphincter of oddi dysfunction

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410071

Locations
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53151
Sponsors and Collaborators
Wisconsin Center for Advanced Research
Aurora Health Care
Investigators
Principal Investigator: Nalini M Guda, MD GI Associates
  More Information

No publications provided

Responsible Party: Nalini Guda MD, Wisconsin Center for Advanced Research, Division of GI Associates LLC
ClinicalTrials.gov Identifier: NCT01410071     History of Changes
Other Study ID Numbers: S-05-130E
Study First Received: August 2, 2011
Last Updated: August 3, 2011
Health Authority: USA: Institutional Review Board

Keywords provided by Wisconsin Center for Advanced Research:
Sphincter of Oddi Dysfunction

Additional relevant MeSH terms:
Abdominal Pain
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Sphincter of Oddi Dysfunction
Pain
Signs and Symptoms
Digestive System Diseases
Biliary Dyskinesia
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014