A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Duke University

Status: Completed

Conditions: Pancreatitis

Treatments: Drug: aprepitant; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00736073

Pro00005149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

aprepitant

Treatment:

Drug: aprepitant

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo