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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
cutting the biliary sphincter muscle (sphincterotomy)
ERCP with sphincter manometry, but no sphincterotomy
Yale University
New Haven, Connecticut, United States
Indiana University
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Midwest Therapeutic Endoscopy Consultants
St Louis, Missouri, United States
Percentage of Participants With Success
The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of \<6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the window, then the 6-month value was used when available.
Time frame: 1 year
Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.
Successful outcome was defined using the primary outcome definition of success at 12 months post randomization. Abnormal sphincter manometry was determined as a basal pressure of more than 40mm Hg in both leads.
Time frame: 1 year
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Medical University of South Carolina Digestive Disease Center
Charleston, South Carolina, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States