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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: IgG4-related Sclerosing Cholangitis; Autoimmune Pancreatitis; Obstructive Jaundice

Treatments: Procedure: biliary stent; Drug: corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT02797665

ZS-844

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Steroids group

Active Comparator group

Description:

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

Treatment:

Drug: corticosteroids

Stent group

Active Comparator group

Description:

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

Treatment:

Drug: corticosteroids

Procedure: biliary stent