- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01583517
ERCP in Idiopathic Recurrent Acute Pancreatitis
Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with idiopathic RAP, defined as ≥2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, will be prospectively enrolled. All patients will undergo ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If <40mmHg, the patient will be randomized to sham or biliary sphincterotomy (BES). If ≥40mmHg, the patient will be randomized to BES or pancreatobiliary ("dual") sphincterotomy (DES).
Patients and physicians will not be blinded to the assignment group. Patients will be followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP).
Differences between patients who did and did not develop RAP during follow-up will be compared to evaluate for factors associated with AP during follow-up.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Health University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
- ERCP with SOM planned
Exclusion Criteria:
- Chronic pancreatitis
- Pancreas divisum
- Alternate etiology identified (e.g., CBD stone, IPMN)
- Inability to perform pancreatic manometry
- Pregnancy, age < 18, incarceration
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Biliary sphincterotomy
Cutting of the biliary sphincter muscle alone
|
Cutting of the biliary sphincter muscle.
|
Active Comparator: Dual sphincterotomy
Cutting of both the biliary and pancreatic sphincter muscles.
|
Cutting of both the biliary and pancreatic sphincter muscles.
|
Sham Comparator: Sham
Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).
|
No sphincterotomy is performed in patients randomized to sham with normal SOM.
|
Active Comparator: Biliary sphincterotomy - Normal SOM
Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.
|
Cutting of the biliary sphincter muscle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrent acute pancreatitis
Time Frame: 120 months
|
Patients will be followed post-ERCP for up to 10 years. The primary outcome is development of acute pancreatitis following the index ERCP, based on standard definitions. Acute pancreatitis is defined as new onset of pancreatic-type abdominal pain with associated elevation in serum amylase or lipase > 3 times the upper limit of normal, OR radiographic findings consistent with acute pancreatitis. |
120 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interval development of chronic pancreatitis
Time Frame: 120 months
|
Determine the incidence of chronic pancreatitis during prolonged follow-up.
Chronic pancreatitis is defined as characteristic changes on cross sectional imaging (CT or MRI/MRCP) or ERP (Cambridge classification).
|
120 months
|
Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up
Time Frame: 120 months
|
A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up
|
120 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stuart Sherman, MD, Indiana University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1011003897
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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