ERCP in Idiopathic Recurrent Acute Pancreatitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01583517
First received: April 20, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention
Recurrent Acute Pancreatitis
Procedure: Biliary sphincterotomy
Procedure: Pancreatobiliary sphincterotomy
Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Recurrent acute pancreatitis [ Time Frame: 120 months ] [ Designated as safety issue: No ]

    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:
  • Interval development of chronic pancreatitis [ Time Frame: 120 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 120 months ] [ Designated as safety issue: No ]
    A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up


Enrollment: 89
Study Start Date: September 1997
Estimated Study Completion Date: August 2016
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biliary sphincterotomy
Cutting of the biliary sphincter muscle alone
Procedure: Biliary sphincterotomy
Cutting of the biliary sphincter muscle.
Active Comparator: Dual sphincterotomy
Cutting of both the biliary and pancreatic sphincter muscles.
Procedure: Pancreatobiliary sphincterotomy
Cutting of both the biliary and pancreatic sphincter muscles.
Sham Comparator: Sham
Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).
Procedure: Sham
No sphincterotomy is performed in patients randomized to sham with normal SOM.
Active Comparator: Biliary sphincterotomy - Normal SOM
Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.
Procedure: Biliary sphincterotomy
Cutting of the biliary sphincter muscle.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583517

Locations
United States, Indiana
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Stuart Sherman, MD Indiana University
  More Information

No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01583517     History of Changes
Other Study ID Numbers: 1011003897
Study First Received: April 20, 2012
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Acute pancreatitis
ERCP
Sphincterotomy
Manometry
Sphincter of Oddi dysfunction

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 20, 2014