Medical University Of South Carolina Leads Multicenter Study Evaluating Biliary Sphincter Disorder

Main Category: GastroIntestinal / Gastroenterology
Also Included In: MRI / PET / Ultrasound;  Clinical Trials / Drug Trials
Article Date: 27 Sep 2007 - 0:00 PDT

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The Medical University of South Carolina (MUSC) will lead a $6 million study to determine the best techniques for diagnosing and treating sphincter of Oddi dysfunction (SOD), a painful condition that causes narrowing or spasm of the muscle that controls the flow of bile and pancreatic juice into the small intestine.

The national principal investigator for this five year, multicenter, research project is Peter Cotton, MD, professor of medicine gastroenterology and hepatology and founder of the Digestive Disease Center at MUSC.

The study, called Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD), is funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health and involves five other major research sites.

More than half a million patients undergo surgical removal of the gallbladder (cholecystectomy) annually in the United States, predominantly for gallbladder disease. Although most operations are successful, 10 to 20 percent of patients report persistent episodes of pain after surgery.

Some of these patients are found to have new gallstones, or other conditions such as pancreatitis. When these causes are excluded, SOD is suspected. Dysfunction of the sphincter (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, including those involved in the study, and undergo multiple tests.

The standard treatment is endoscopic retrograde cholangiopancreatography (ERCP), which allows complete documentation of the relevant anatomy, assessment of any sphincter spasm by measuring the pressure with manometry, and immediate treatment by cutting the sphincter (sphincterotomy).

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.

Dr. 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.

Medical University of South Carolina
http://www.musc.edu