ERCP in Idiopathic Recurrent Acute Pancreatitis

Indiana University89 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Acute Pancreatitis

Interventions

Biliary sphincterotomyPROCEDURE

Cutting of the biliary sphincter muscle.

Pancreatobiliary sphincterotomyPROCEDURE

Cutting of both the biliary and pancreatic sphincter muscles.

ShamPROCEDURE

No sphincterotomy is performed in patients randomized to sham with normal SOM.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 120 months

Secondary Outcomes

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).

Time frame: 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

Time frame: 120 months

Data from ClinicalTrials.gov

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