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
| Registry | NCT01410071 |
|---|---|
| Status | Terminated - Analysis of designed comparison groups not viable |
| Study type | Observational |
| Enrollment | 153 (Actual) |
| Sponsor | Wisconsin Center for Advanced Research (Other); collaborators: Wake Forest University Health Sciences |
| Conditions | Sphincter of Oddi Dysfunction, Abdominal Pain |
| Dates | start 2005-09-01, primary completion 2009-06-01, completion 2009-08-01, first posted 2011-08-04, last updated 2011-08-04 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| sphincter of oddi dysfunction | endoscopic therapy vs conservative care |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Wisconsin Center for Advanced Research | Milwaukee, Wisconsin | United States |