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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01410071
Recruitment Status : Terminated (Analysis of designed comparison groups not viable)
First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Aurora Health Care
Information provided by:
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.

Condition or disease
Sphincter of Oddi Dysfunction Abdominal Pain

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.

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Study Type : Observational
Actual Enrollment : 153 participants
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
Study Start Date : September 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

sphincter of oddi dysfunction
endoscopic therapy vs conservative care

Primary Outcome Measures :
  1. symptom improvement [ Time Frame: one year ]

Secondary Outcome Measures :
  1. improved quality of life [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
physician's private practice/clinic patients presenting with suspected sphincter of oddi dysfunction

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01410071

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

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Responsible Party: Nalini Guda MD, Wisconsin Center for Advanced Research, Division of GI Associates LLC Identifier: NCT01410071     History of Changes
Other Study ID Numbers: S-05-130E
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011
Keywords provided by Wisconsin Center for Advanced Research:
Sphincter of Oddi Dysfunction
Additional relevant MeSH terms:
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Sphincter of Oddi Dysfunction
Abdominal Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Biliary Dyskinesia
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases