Feature Study
SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)

Link to SHARP research trial video on YouTube.
Link to SHARP research trial video on YouTube.

The purpose of the SHARP study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors use a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas.

SHARP logo

People who have: [1] been diagnosed with pancreas divisum; [2] have had at least two episodes of pancreatitis; and, [3] are candidates for the ERCP with sphincterotomy procedure, may be eligible to participate in this study. Participants will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure.

Participants will have follow-up visits 30 days after the procedure, six months after the procedure, and continuing every six months until a maximum follow-up period of 48 months.

The study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. The investigator in charge of this study at MUSC is Dr. Gregory Cote. The study is being done at approximately 20 sites in North America and Europe. Approximately 240 people will take part study-wide.

ClinicalTrials.gov NCT#03609944