Conditions: Pancreatitis
Keywords: pancreatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 73
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.

Detailed description:
This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP. Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result in pain and lead to hospitalization and, in some cases, a need for further procedures such as surgery.

Aprepitant is a medication that is currently used to prevent nausea and vomiting in some patients caused by chemotherapy for the treatment of cancer. It is also approved for the prevention of post-operative nausea and vomiting. There is theoretical evidence from animal studies that the way in which Aprepitant works in the body may prevent pancreatitis.

Arms:
arm 1: aprepitant arm 2: Placebo

Interventions: intervention 1: aprepitant intervention 2: Placebo
Intervention descriptions: intervention 1: one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose intervention 2: one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose

Protocol document: