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ERCP in Idiopathic Recurrent Acute Pancreatitis

NCT01583517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2014-10-10

No results posted yet for this study

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).

Conditions

  • Recurrent Acute Pancreatitis

Interventions

PROCEDURE

Biliary sphincterotomy

Cutting of the biliary sphincter muscle.

PROCEDURE

Pancreatobiliary sphincterotomy

Cutting of both the biliary and pancreatic sphincter muscles.

PROCEDURE

Sham

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Stuart Sherman, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-30
Primary Completion
2012-04-30
Completion
2014-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583517 on ClinicalTrials.gov