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MUSC leads $6M study evaluating biliary sphincter disorder by Kathleen Ellis Business Development & Marketing Services MUSC will lead a $6 million study to determine the best techniques for diagnosing and treating a painful condition that causes narrowing or spasm of the muscle that controls the flow of bile and pancreatic juice into the small intestine.   Called Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD), the five-year, research project is funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and involves five other major research sites. The national study’s principal investigator is MUSC’s Peter Cotton, M.D., professor of medicine, gastroenterology and hepatology, and founder of the Digestive Disease Center.   Each year in the United States, more than 500,000 patients undergo surgical removal of the gallbladder through a procedure called cholecystectomy, predominantly due to gallbladder disease. Although most operations are successful, 10 percent to 20 percent of patients report persistent episodes of pain after surgery.   Some of these patients are found to have developed new gallstones, or other conditions such as pancreatitis. When these causes are excluded, a condition known as sphincter of oddi dysfunction (SOD) is suspected. Dysfunction of the sphincter, by way of narrowing or spasm, can cause back pressure in the liver or pancreas, resulting in severe attacks of pain and significant interference with daily living.   The focus of this study is to clarify how best to detect and exclude SOD, and how best to treat it. Currently, patients with suspected SOD are usually referred to special centers, such as those involved in the study, and undergo multiple tests.   The standard treatment is endoscopic retrograde cholangiopancreatography (ERCP), a combined endoscopic and fluoroscopic technique used to diagnose and treat problems of the biliary and pancreatic duct systems.   This process has not been subjected to controlled scientific trial, which is deemed necessary for two reasons: only about 60 percent of these patients experience lasting relief; and both ERCP and sphincterotomy carry significant risks.   EPISOD is aimed at determining the best candidates for treatment by analyzing the patients’ characteristics (pain patterns, presence of other digestive function disorders and psychological factors), measuring the sphincter pressures at ERCP and allocating treatment to sphincterotomy or control. Study participants will be followed for at least one year to assess their outcomes and need for further treatment.   Results of the EPISOD trial should provide patients and practitioners with the scientific evidence to more effectively and safely treat patients with suspected SOD.   Cotton’s colleagues on this study include researchers from MUSC; the University of North Carolina; the University of Michigan; Johns Hopkins University; Indiana University; the University of Alabama; Virginia Mason Medical Center, Seattle; and the University of Minnesota, Minneapolis.     Friday, Oct. 19, 2007 Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Island Publications at 849-1778, ext. 201.