Clinical Trial: Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase III Randomized Multicenter Clinical Trial of Sphincterotomy for the Treatment of SOD III Patients
Brief Summary: The Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction(SOD) study (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of Oddi dysfunction type III.
Detailed Summary:
Clinical Trial Phase: Phase III
Study Sites Seven clinical centers in US
Study Period Planned enrollment period - 3 years
Planned duration of the study - 5 years
Study Population SOD III Patients
Primary Study Objective: To ascertain whether subjects with SOD III respond to sphincterotomy,
Secondary Study Objectives
To evaluate:
- the association between the results of Sphincter of Oddi Manometry (SOM) (abnormal/normal) and the primary outcome (success/failure);
- 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;
- the effects of pre-specified prognostic factors on the primary outcome;
- anxiety and depression scores over time and their relation to study outcomes;
- the economic impact of SOD III, and of endoscopic sphincterotomy in patients with SOD III; and, to,
- conduct a careful follow-up study (EPISOD2) of standard of care treatment (separate protocol).
Study Design The EPISOD Trial is a parallel, randomized, double-blinded, sham-controlled, multicenter Phase III clinical trial of endoscopic sphincterotomy as treatment for adults 18 to 65 years of age diagnosed wi
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Current Primary Outcome: Percentage of Participants With Success [ Time Frame: 1 year ]
Original Primary Outcome: To ascertain whether subjects with SOD III respond to sphincterotomy, [ Time Frame: 5 years ]
Current Secondary Outcome: Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry. [ Time Frame: 1 year ]
Original Secondary Outcome: the association between the results of Sphincter of Oddi Manometry (SOM) (abnormal/normal) and the primary outcome (success/failure) [ Time Frame: 5 years ]
Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dates:
Date Received: May 30, 2008
Date Started: July 2008
Date Completion: December 2016
Last Updated: June 17, 2016
Last Verified: June 2016