Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction
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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 |
- symptom improvement [ Time Frame: one year ] [ Designated as safety issue: No ]
- 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 |
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
Contacts and Locations| United States, Wisconsin | |
| Wisconsin Center for Advanced Research | |
| Milwaukee, Wisconsin, United States, 53151 | |
| 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 June 18, 2013