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EPISOD research study starts at MUSC

The clinical research study "Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction" (EPISOD) is being coordinated by Dr Peter Cotton and team members of the Digestive Disease Research Center and the Data Coordination Unit at MUSC. Sphincter of Oddi Dysfunction (SOD) is a controversial topic, usually considered in patients with pain after cholecystectomy. Many such patients are referred from around the Southeastern States, to the Pancreato-biliary group at MUSC, since the best methods for evaluation and treatment are unclear. ERCP (Endoscopic Retrograde Cholangio-Pancreatography) with sphincter manometry are usually performed, with sphincterotomy of the biliary and/or pancreatic sphincters if raised pressure is found. However, the predictive value of these measurements is unknown, and the whole procedure does carry some risk. This trial is designed to clarify these and other issues, using a randomized and blinded study design. It is funded for 5 years (and at over $6m) by the National Institute of Diabetes and Digestive and Kidney Diseases, and will include 5 other tertiary referral centers in Alabama, Maryland, Indianapolis, Minneapolis, and Seattle. The NIDDK does not usually fund clinical studies of this nature and size, and MUSC is proud to have received this opportunity.

Dr Joe Romagnuolo is the Principal Investigator at the MUSC site. The program manager is Kyle Orrell in the DDC. The data coordination center of this trial is headed by Dr Valerie Durkalski in MUSC’s Department of Biostatistics, Bioinformatics, and Epidemiology, which is using a unique purpose-designed web based data collection system. The plan is to enroll a total of 314 subjects into different arms of the trial and to follow them for at least one year. The team hopes to be able to learn much more about the syndrome of "suspected SOD" and the best diagnostic and therapeutic approaches.

Digestive Disease Center - http://www.ddc.musc.edu

Data Coordination Unit - http://www.dcu.musc.edu

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