Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction — EPISOD  

Sphincter of Oddi Dysfunction Clinical Trial

Official title: A Phase III Randomized Multicenter Clinical Trial of Sphincterotomy for the Treatment of SOD III Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 with SOD III.

Sample Size A minimum of 214 subjects will be randomized using a 2:1 allocation in favor of sphincterotomy and will be followed for 12 months post-randomization. ;

Related Conditions & MeSH terms

• Sphincter of Oddi Dysfunction

• NCT number: NCT00688662
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Completion date: December 2016