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

Not Applicable

• Conditions: Autoimmune Pancreatitis; IgG4-related Sclerosing Cholangitis; Obstructive Jaundice
• Interventions: Drug: corticosteroids; Procedure: biliary stent

• Registration Number: NCT02797665
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-13
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-12
• Last Update Posted: 2020-07-14
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent group	corticosteroids	The patients will be treated with oral corticosteroids and biliary stent.
Stent group	biliary stent	The patients will be treated with oral corticosteroids and biliary stent.
Steroids group	corticosteroids	The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.

Primary Outcome Measures

Name	Time	Method
Clinical remission rate of obstructive jaundice	Day 60

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China