BACKGROUND: Pancreatitis is one of the most common complications associated with ERCP. Multiple factors have been implicated for this potentially serious complication. Numerous suggestions for minimizing risks at ERCP have been offered, one of which is to use nonionic, low osmolarity contrast agents for pancreatic injection. Results of previous studies comparing different contrast media have been inconclusive. METHODS: To evaluate the role contrast material plays in the development of post-ERCP pancreatitis, the Midwest Pancreaticobiliary Group performed a prospective double-blind controlled study. A total of 1,979 consecutive ERCP patients were enrolled, and 1,659 patients with pancreatic duct injections were divided into subgroups according to the complexity of the ERCP. Post-ERCP pancreatitis was compared between similar groups. Patients were randomized to receive injections of nonionic, low osmolarity contrast or standard ionic contrast media. RESULTS: The overall incidence of post-procedural pancreatitis was 10.2%. Those with diagnostic ERCP had the lowest incidence at 5.6%. Therapeutic procedures (12.3%) and sphincter of Oddi manometry (15.2%) had higher rates. Those injected with standard (ionic) contrast had an incidence of 10.4% and after injection with lower osmolar (nonionic) contrast, there was a 10% post-procedural pancreatitis rate. CONCLUSIONS: Patients with more complex procedures develop pancreatitis more frequently. The use of low osmolar (nonionic) contrast media does not decrease the incidence of post-ERCP pancreatitis.
RCT Entities:
BACKGROUND:Pancreatitis is one of the most common complications associated with ERCP. Multiple factors have been implicated for this potentially serious complication. Numerous suggestions for minimizing risks at ERCP have been offered, one of which is to use nonionic, low osmolarity contrast agents for pancreatic injection. Results of previous studies comparing different contrast media have been inconclusive. METHODS: To evaluate the role contrast material plays in the development of post-ERCP pancreatitis, the Midwest Pancreaticobiliary Group performed a prospective double-blind controlled study. A total of 1,979 consecutive ERCP patients were enrolled, and 1,659 patients with pancreatic duct injections were divided into subgroups according to the complexity of the ERCP. Post-ERCP pancreatitis was compared between similar groups. Patients were randomized to receive injections of nonionic, low osmolarity contrast or standard ionic contrast media. RESULTS: The overall incidence of post-procedural pancreatitis was 10.2%. Those with diagnostic ERCP had the lowest incidence at 5.6%. Therapeutic procedures (12.3%) and sphincter of Oddi manometry (15.2%) had higher rates. Those injected with standard (ionic) contrast had an incidence of 10.4% and after injection with lower osmolar (nonionic) contrast, there was a 10% post-procedural pancreatitis rate. CONCLUSIONS:Patients with more complex procedures develop pancreatitis more frequently. The use of low osmolar (nonionic) contrast media does not decrease the incidence of post-ERCP pancreatitis.