Pancreatitis Clinical Trial
Official title:
Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial
One of the major elements of successful endoscopic retrograde cholangiopancreatography (
ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various
factors may adversely affect the cannulation procedure of the CBD leading to complications
(acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic
sphincterotomy is frequently required for interventional procedures (eg stone extraction).
During sphincterotomy, incision of the orifice of the papilla will be performed by using a
sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of
acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the
papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can
be performed. As a result, bleeding complications and scarring as late effects might be
prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when
using a balloon catheter.
This study aims to evaluate the incidence of acute pancreatitis and other complications after
ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic
sphincterotomy in a randomized multicenter setting.
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