NCT00688662

Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Sphincter of Oddi Dysfunction

Interventions

Type	Name	Description
PROCEDURE	ERCP with sphincterotomy	cutting the biliary sphincter muscle (sphincterotomy)
PROCEDURE	ERCP without sphincterotomy	ERCP with sphincter manometry, but no sphincterotomy

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-12-01
• Completion: 2016-12-01
• First posted: 2008-06-03
• Last updated: 2018-04-19
• Results posted: 2016-07-28

Locations

7 sites across 1 country: United States