ERCP in Idiopathic Recurrent Acute Pancreatitis

Study Overview
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Brief Summary
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The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).

Detailed Description
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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.

Official Title
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Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis

Conditions
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Recurrent Acute Pancreatitis

Intervention / Treatment
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* Procedure: Biliary sphincterotomy
* Procedure: Pancreatobiliary sphincterotomy
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biliary sphincterotomy<br>Cutting of the biliary sphincter muscle alone | Procedure: Biliary sphincterotomy<br>* Cutting of the biliary sphincter muscle.<br>|
| Active Comparator: Dual sphincterotomy<br>Cutting of both the biliary and pancreatic sphincter muscles. | Procedure: Pancreatobiliary sphincterotomy<br>* Cutting of both the biliary and pancreatic sphincter muscles.<br>|
| Sham Comparator: Sham<br>Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy). | Procedure: Sham<br>* No sphincterotomy is performed in patients randomized to sham with normal SOM.<br>|
| Active Comparator: Biliary sphincterotomy - Normal SOM<br>Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone. | Procedure: Biliary sphincterotomy<br>* Cutting of the biliary sphincter muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent acute pancreatitis | 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 | 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 | A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up | 120 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute pancreatitis, ERCP, Sphincterotomy, Manometry, Sphincter of Oddi dysfunction