- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02797665
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
July 12, 2020 updated by: Peking Union Medical College Hospital
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Aiming Yang, M.D.
- Phone Number: +86-10-69151593
- Email: yangaiming@medmail.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Steroids group
The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.
|
prednisone 0.6mg/kg/d
|
Active Comparator: Stent group
The patients will be treated with oral corticosteroids and biliary stent.
|
prednisone 0.6mg/kg/d
placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical remission rate of obstructive jaundice
Time Frame: Day 60
|
Day 60
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aiming Yang, M.D., Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
June 6, 2016
First Submitted That Met QC Criteria
June 8, 2016
First Posted (Estimate)
June 13, 2016
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 12, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Skin Manifestations
- Biliary Tract Diseases
- Pancreatic Diseases
- Bile Duct Diseases
- Hyperbilirubinemia
- Pancreatitis, Chronic
- Pancreatitis
- Cholangitis
- Cholangitis, Sclerosing
- Jaundice
- Jaundice, Obstructive
- Autoimmune Pancreatitis
Other Study ID Numbers
- ZS-844
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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