Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2021-12-31

Brief Summary

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This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half of participants will receive corticosteroids alone, while the other half will receive corticosteroids with biliary stent at the beginning.

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Detailed Description

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Conditions

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Autoimmune Pancreatitis IgG4-related Sclerosing Cholangitis Obstructive Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Steroids group

The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.

Group Type ACTIVE_COMPARATOR

corticosteroids

Intervention Type DRUG

prednisone 0.6mg/kg/d

Stent group

The patients will be treated with oral corticosteroids and biliary stent.

Group Type ACTIVE_COMPARATOR

corticosteroids

Intervention Type DRUG

prednisone 0.6mg/kg/d

biliary stent

Intervention Type PROCEDURE

placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)

Interventions

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corticosteroids

prednisone 0.6mg/kg/d

Intervention Type DRUG

biliary stent

placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adults greater than 18 years-old;
* autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
* obstructive jaundice

Exclusion Criteria

* malignancies; active infections;
* pregnancy or breast feeding;
* standard contraindications to ERCP;
* unwillingness or inability to consent for the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No