At a glance
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SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)
In Brief
A clinical study evaluating ERCP with miES and EUS for Pancreatitis and 4 related conditions. Completed, enrolled 181 participants across 21 sites in 2 countries.
Detailed Summary
The purpose of this 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 used 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. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be 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, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months.
Study Details
Timeline
Interventions
Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
Endoscopic ultrasound