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

Not Applicable

Completed

• Conditions: Pancreatitis
• Interventions: Drug: aprepitant; Drug: Placebo

• Registration Number: NCT00736073
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2010-08
• Study Completion: 2012-11
• Results First Submitted: 2012-11-15
• Results First Submitted QC: 2013-03-11
• Results First Posted: 2013-04-19
• Status Verified: 2015-04
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	aprepitant	aprepitant
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).	48 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis	48 hours post ERCP and 1 week post ERCP
Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis	7 days

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States