Project Details
Description
Acute pancreatitis is among the most common gastrointestinal causes for hospitalization in the U.S. Roughly one in five patients with acute pancreatitis will have recurrent bouts. Recurrent acute pancreatitis (RAP) is a strong risk factor for progression to chronic pancreatitis, an irreversible fibroinflammatory disease that greatly impacts quality of life, and is also a risk factor for pancreatic cancer. We have designed a sham-controlled, single blinded with a blinded outcome assessment, multi-center, randomized clinical trial of endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) for the treatment of recurrent acute pancreatitis (RAP) with pancreas divisum. Primary outcome: Reduce the risk of subsequent acute pancreatitis episodes by 33%. To test this hypothesis, we will compare the incidence of acute pancreatitis > 28 days after treatment allocation as the primary outcome measure, using the next attack of acute pancreatitis as a time-to-event outcome.
Status | Finished |
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Effective start/end date | 9/1/18 → 8/31/21 |
Funding
- Medical University of South Carolina (A00-3656-S009 // 5U01DK116743-03)
- National Institute of Diabetes and Digestive and Kidney Diseases (A00-3656-S009 // 5U01DK116743-03)
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