This study is no longer accepting patients.
A Clinical Research Trial listed on
clinicaltrials.gov
Protocol Title: Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction(SOD) Acronym EPISOD.
Clinical Trial Phase: Phase III
Study Sites; Eight clinical centers in US
Study Period Planned enrollment period - 3 years
Planned duration of the study - 5 years
Study Population SOD Patients
Primary Study Objective: To ascertain whether
subjects with SOD respond to sphincterotomy
Secondary Study Objectives:
To evaluate:
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the association between the results of Sphincter of Oddi Manometry (SOM) (abnormal/normal) and the primary outcome (success/failure);
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the success rate (as defined in the primary) of subjects who receive biliary sphincterotomy alone versus subjects who receive both biliary and pancreatic sphincterotomy in the subgroup of patients with manometrically proven hypertension of the pancreatic sphincter;
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the effects of pre-specified prognostic factors on the primary outcome;
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anxiety and depression scores over time and their relation to study outcomes;
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the economic impact of SOD, and of endoscopic sphincterotomy in patients with SOD;
Primary Eligibility Criteria:
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18 – 65 years of age
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Must have had your gallbladder removed
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Can not have had prior ERCP treatment
- Meet all other criteria listed on http://clinicaltrials.gov/ct2/show/NCT00688662?term=episod&rank=1