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

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ClinicalTrials.gov Identifier: NCT02797665
Recruitment Status : Active, not recruiting
First Posted : June 13, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autoimmune Pancreatitis IgG4-related Sclerosing Cholangitis Obstructive Jaundice Drug: corticosteroids Procedure: biliary stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Active Comparator: Steroids group
The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.
Drug: corticosteroids
prednisone 0.6mg/kg/d

Active Comparator: Stent group
The patients will be treated with oral corticosteroids and biliary stent.
Drug: corticosteroids
prednisone 0.6mg/kg/d

Procedure: biliary stent
placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)




Primary Outcome Measures :
  1. Clinical remission rate of obstructive jaundice [ Time Frame: Day 60 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797665


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Aiming Yang, M.D. Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02797665     History of Changes
Other Study ID Numbers: ZS-844
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Pancreatitis
Cholangitis
Cholangitis, Sclerosing
Jaundice
Jaundice, Obstructive
Pancreatic Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms