Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD)
Number of Subjects in Study Archive: 214
Study Design: Interventional
Conditions: Sphincter of Oddi Dysfunction
Duration: July 2008 – December 2013 (primary outcome), August 2016 (secondary outcomes)
# Recruitment Centers: 7
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: https://clinicaltrials.gov/ct2/show/NCT00688662
Postcolecystectomy pain is a common clinical problem for the more than 70,000 patients who undergo this procedure annually. Of those 70,000 patients, at least 10% report experiencing pain following the procedure. Patients who have no significant abnormalities on imaging or laboratory testing often undergo endoscopic retrograde cholangiopancreatography (ERCP) in hopes of finding stones or other pathology. The current practice of performing ERCP in these patients is not supported by evidence, causing several authors to express concerns about the procedure. Patients who do not benefit from the procedure often undergo more ERCPs and surgical interventions.
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.
To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief.
Primary Outcome Measures: To ascertain whether subjects with SOD III respond to sphincterotomy
Secondary Outcome Measures: determine the association between the results of Sphincter of Oddi Manometry (SOM) and the primary outcome
- Patients between the ages of 18 and 65 who have been diagnosed with the clinical syndrome of SOD and who have had a cholecystectomy more than 90 days before enrolling may participate in this study.
- Patients younger than 18 or older than 65, or any patients who have had a prior ERCP treatment, prior gastric resection, or surgery involving biliary division may not participate in this study.
- Patients with pancreas divisum, any pathology found at ERCP (except hypertension), or failed pancreatic manometry.
In patients with abdominal pain after cholecystectomy undergoing ERCP with manometry, sphincterotomy vs sham did not reduce disability due to pain. These findings do not support ERCP and sphincterotomy for these patients.
This study is ongoing regarding the secondary outcomes.