Pancreatitis
Conditions
Keywords
pancreatitis
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.
Interventions
DRUGaprepitant
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
DRUGPlacebo
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
Sponsors
Merck Sharp & Dohme LLC
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Subjects scheduled for ERCP as outpatient procedure in Duke clinic between Aug 2007 and October 2009
Pre-assignment details
Investigational product to be given 4 hours before procedure
Participants by arm
| Arm | Count |
|---|---|
| Arm 1-medication Pre and Post Procedure aprepitant
aprepitant : 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 | 34 |
| Arm 2-Randomized to Placebo Placebo
Placebo : 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 | 39 |
| Total | 73 |
Baseline characteristics
| Characteristic | Arm 2-Randomized to Placebo | Arm 1-medication Pre and Post Procedure | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 34 Participants | 73 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 12 | 50 years STANDARD_DEVIATION 17 | 48 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 39 participants | 34 participants | 73 participants |
| Sex: Female, Male Female | 30 Participants | 25 Participants | 55 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 39 |
| serious Total, serious adverse events | 7 / 34 | 7 / 39 |
Outcome results
Primary
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).
Time frame: 48 hours
Population: The number of participants who received the aprepitant or placebo were evaluated for ERCP pancreatitis. Each case of ERCP pancreatitis was tracked for the participant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1-medication Pre and Post Procedure | 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). | 7 cases of ERCP in participants |
| Arm 2-Randomized to Placebo | 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). | 7 cases of ERCP in participants |
Secondary
Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis
Time frame: 48 hours post ERCP and 1 week post ERCP
Population: There are 2 telephone assessments that participants are required to complete in order to analyze the outcome measure. The study team was unable to collect both assessments within the required timeframe due missed calls \& lack of return calls from participants. Therefore data collection and analysis could not be completed per protocol.
Secondary
Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1-medication Pre and Post Procedure | Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis | 6 participants |
| Arm 2-Randomized to Placebo | Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis | 9 participants |