CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 214 enrolled
Drug / intervention
ERCP with sphincterotomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00688662
NCT00688662N/ACompleted
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A Phase III Randomized Multicenter Clinical Trial of Sphincterotomy for the Treatment of SOD III Patients

Medical University of South Carolina·interventional·Posted Jun 3, 2008·Updated Apr 19, 2018

In Brief

A clinical study evaluating ERCP with sphincterotomy and ERCP without sphincterotomy for Sphincter of Oddi Dysfunction. Completed, enrolled 214 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSphincter of Oddi Dysfunction
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2013
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.1 years ago

Interventions

ERCP with sphincterotomyprocedure

cutting the biliary sphincter muscle (sphincterotomy)

ERCP without sphincterotomyprocedure

ERCP with sphincter manometry, but no sphincterotomy