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, meaning that you will be treated as if you are having the ERCP with sphincterotomy procedure but the procedure will not really be performed. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until the study ends.
Chronic pancreatitis is a scarring condition of the pancreas that often results in debilitating pain. When pancreatic duct drainage appears to be impaired by the presence of a blocking stone or scar tissue, pancreatic endotherapy (procedures performed through the mouth using a lighted tube with special instruments to enter the pancreatic duct) is often offered in clinical practice. The rationale for this study is that while pancreatic endotherapy is logical, there are limited studies to suggest it helps patients with their pain. Furthermore, these procedures are costly and have potential risks. This is a preliminary study to perform the first sham (like a placebo) study of pancreatic endotherapy in patients with chronic pancreatitis and evidence of impaired pancreatic duct drainage by radiology scans.
The objectives of this study are to: 1) determine the feasibility of a sham-controlled pancreatic endotherapy trial, and 2) optimize enrollment criteria and outcome measures for a subsequent, definitive study.