SHARP Trial
Help us to find the best course of treatment for individuals with Pancreas Divisum and Acute Pancreatitis
About the Study
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that combines upper gastrointestinal (GI) endoscopy and x-ray to treat problems of the bile and pancreatic ducts. A gastroenterologist uses a long, flexible tube with a light and camera to examine the inside of the digestive system. ERCP with minor papilla sphincterotomy (cutting of the opening of the pancreatic duct) is a promising treatment option for those with pancreas divisum and acute pancreatitis, but there is limited research on it's effectiveness.
The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a clinical trial supported by the National Institute of Health (NIH) with more than 15 medical centers in the United States, Canada and Europe. The goal of the study is to determine if the ERCP procedure benefits patients with recurrent acute pancreatitis and pancreas divisum.
Eligibility
Study Overview
Study Sites
Harvard Medical School, Boston, MA
Health Sciences Centre, Winnipeg, MB, Canada
IU Health University Hospital, Indianapolis, IN
Keck Hospital of USC, Los Angeles, CA
Medical University of South Carolina University Hospital, Charleston, SC
Methodist Dallas Medical Center, Dallas, TX
Northwestern Memorial Hospital, Chicago, IL
OSU Wexner Medical Center, Columbus, OH
Oregon Health and Science University, Portland, OR
Saint Luke's Hospital of Kansas City, Kansas City, MO
UCSF Medical Center, San Francisco, CA
University of Arkansas for Medical Sciences, Little Rock, AR
University of Minnesota Medical Center Hospital, Minneapolis, MN
UPMC Presbyterian Hospital, Pittsburgh, PA
University of Rochester, Rochester, NY
UVA Medical Center, Charlottesville, VA
Did you know?
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About 10% of individuals have pancreas divisum
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Pancreas divisum is congenital, meaning it is a condition that is present at or before birth
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Majority of individuals do not know they have pancreas divisum
What happens at study visits?
The first visit will be to discuss the study in further depth, confirm eligibility, and answer any questions you may have regarding the study. You will also be asked to answer some questionnaires.
The next visit will be randomization of the procedures. This is an outpatient procedure.
You will be asked to come back in at the 30 day follow up for an x-ray and at the 18 month follow up for an MRI. You will also be asked to answer some questions about how you are feeling.
Why should I participate?
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Help determine the best treatment for individuals that have pancreas divisum
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Close medical monitoring for the duration of the study
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A chance to help others dealing with the same condition as you
SHARP INFORMATIONAL VIDEO
This NIH-sponsored Randomized Clinical Trial is currently enrolling subjects to learn whether ERCP with sphincterotomy is beneficial in patients with acute recurrent pancreatitis and pancreas divisum.
