ERCP in Idiopathic Recurrent Acute Pancreatitis

Not Applicable

Completed

• Conditions: Recurrent Acute Pancreatitis
• Interventions: Procedure: Biliary sphincterotomy; Procedure: Pancreatobiliary sphincterotomy; Procedure: Sham

• Registration Number: NCT01583517
• Lead Sponsor: Indiana University

Brief Summary

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

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 Timeline

• Study Start: 1997-09
• Primary Completion: 2012-04
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Biliary sphincterotomy	Biliary sphincterotomy	Cutting of the biliary sphincter muscle alone
Biliary sphincterotomy - Normal SOM	Biliary sphincterotomy	Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.
Dual sphincterotomy	Pancreatobiliary sphincterotomy	Cutting of both the biliary and pancreatic sphincter muscles.
Sham	Sham	Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).

Primary Outcome Measures

Name	Time	Method
Recurrent acute pancreatitis	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.

Secondary Outcome Measures

Name	Time	Method
Interval development of chronic pancreatitis	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).
Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up	120 months	A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up

Trial Locations

Locations (1)

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States