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NCT02797665 Clinical Trial

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

Obstructive Jaundice Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02797665
Other study ID # ZS-844
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date December 2021

Study information
Verified date July 2020
Source Peking Union Medical College Hospital
Contact Aiming Yang, M.D.
Phone +86-10-69151593
Email yangaiming@medmail.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• corticosteroids
prednisone 0.6mg/kg/d
Procedure:
• biliary stent
placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical remission rate of obstructive jaundice Day 60
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