ERCP in Idiopathic Recurrent Acute Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2014-10-31

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).

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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.

Conditions

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Recurrent Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biliary sphincterotomy

Cutting of the biliary sphincter muscle alone

Group Type ACTIVE_COMPARATOR

Biliary sphincterotomy

Intervention Type PROCEDURE

Cutting of the biliary sphincter muscle.

Dual sphincterotomy

Cutting of both the biliary and pancreatic sphincter muscles.

Group Type ACTIVE_COMPARATOR

Pancreatobiliary sphincterotomy

Intervention Type PROCEDURE

Cutting of both the biliary and pancreatic sphincter muscles.

Sham

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

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

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

Biliary sphincterotomy - Normal SOM

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

Group Type ACTIVE_COMPARATOR

Biliary sphincterotomy

Intervention Type PROCEDURE

Cutting of the biliary sphincter muscle.

Interventions

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Biliary sphincterotomy

Cutting of the biliary sphincter muscle.

Intervention Type PROCEDURE

Pancreatobiliary sphincterotomy

Cutting of both the biliary and pancreatic sphincter muscles.

Intervention Type PROCEDURE

Sham

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No