ERCP in Idiopathic Recurrent Acute Pancreatitis

Indiana University

Status: Completed

Conditions: Recurrent Acute Pancreatitis

Treatments: Procedure: Pancreatobiliary sphincterotomy; Procedure: Sham; Procedure: Biliary sphincterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01583517

1011003897

Details and patient eligibility

About

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).

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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89 participants in 4 patient groups

Biliary sphincterotomy

Active Comparator group

Description:

Cutting of the biliary sphincter muscle alone

Treatment:

Procedure: Biliary sphincterotomy

Dual sphincterotomy

Active Comparator group

Description:

Cutting of both the biliary and pancreatic sphincter muscles.

Treatment:

Procedure: Pancreatobiliary sphincterotomy

Sham

Sham Comparator group

Description:

Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).

Treatment:

Procedure: Sham

Biliary sphincterotomy - Normal SOM

Active Comparator group

Description:

Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.

Treatment:

Procedure: Biliary sphincterotomy