The most common significant complication of ERCP is pancreatitis.
In this study, researchers from the United States conducted a prospective, randomized, double-blind, placebo-controlled trial comparing secretin with placebo.
Dr Paul Jowell's team sought to determine whether or not secretin decreased the incidence of post-ERCP pancreatitis.
- secretin group = 10%
- placebo group = 14%
|American Gastroenterological Association|
Overall, 1101 patients were enrolled in this study. However, the team excluded 122 patients, mainly due to protocol violations or because they were lost to follow-up.
The team randomized the remaining 979 (551 female) patients, undergoing ERCP, to receive either 8ml of placebo (n = 491) or 8ml (16µg) of synthetic porcine secretin (n = 488).
They excluded any patients with acute pancreatitis or pancreas divisum from the study.
Both groups were matched in terms of demographics and endoscopic treatments. However, the number of patients with pancreatic duct (PD) stent insertion varied between the 2 groups, 23 of 486 in the secretin group and 42 of 491 in the placebo group.
The researchers administered the secretin, or placebo, when inserting the duodenoscope and prior to cannulation in all patients, except those undergoing manometry. In patients undergoing manometry the drug was administered after the completion of this procedure.
The team assessed all patients immediately after the ERCP, and also by telephone 2 to 4 days later for the primary outcome of pancreatitis.
They measured pain on a scale of 0 to 10, both pre- and post-ERCP.
The researchers made a diagnosis of pancreatitis based on the presence of post-ERCP pain, either with or without other findings of pancreatitis.
The team determined that post-ERCP pancreatitis was significantly reduced in the secretin group, compared with the placebo group, 10% versus 14%, respectively.
They also found that secretin reduced post-ERCP pancreatitis in patients who had a biliary sphincterotomy (5% versus 21%), or cannulation of the common bile duct (7% versus 15%).
Secretin reduces post-ERCP pancreatitis when administered at the time of procedure. It may have a role in reducing the risk of pancreatitis in certain groups of patients, such as those in whom a sphincterotomy is anticipated, the team concluded.