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NCT Number: NCT01583517

ERCP in Idiopathic Recurrent Acute Pancreatitis

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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Key information

Conditions

Recurrent Acute Pancreatitis Bile Duct Diseases Biliary Dyskinesia Biliary Tract Diseases Common Bile Duct Diseases Digestive System Diseases Pancreatic Diseases Pancreatitis Sphincter of Oddi Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biliary sphincterotomy

Procedure

Cutting of the biliary sphincter muscle.

Pancreatobiliary sphincterotomy

Procedure

Cutting of both the biliary and pancreatic sphincter muscles.

Sham

Procedure

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

Primary outcomes

  1. Recurrent acute pancreatitis

    Time frame: 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 outcomes

  1. Interval development of chronic pancreatitis

    Time frame: 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).

  2. Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up

    Time frame: 120 months

    A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2012
Study completion
2014
First posted
Apr 24, 2012
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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