A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 3/30/2013 |
Start Date: | August 2007 |
End Date: | August 2011 |
Contact: | Pat Bixby |
Email: | pat.bixby@duke.edu |
Phone: | 866-704-4673 |
A Randomized, Double-Blind, Prospective Trial of Oral Administration of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
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.
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.
Inclusion Criteria: Patients selected for the study will be those undergoing ERCP who are
at high risk for development of post-ERCP pancreatitis
- patients expected to undergo a sphincterotomy
- patients with suspected sphincter of oddi dysfunction
- patients with a known history in the past of post-ERCP pancreatitis
- patients less than 60 years of age
Exclusion Criteria:
- active pancreatitis
- if they are pregnant
- known adverse reaction to aprepitant
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