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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02797665
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 67
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Clinical remission rate of obstructive jaundice [Day 60]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

• Principal Investigator: Aiming Yang, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT02797665
• Other Study ID Numbers: ZS-844
• First Posted: Jun 13, 2016
• Last Update Posted: Jul 14, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Pancreatitis; Cholangitis; Cholangitis, Sclerosing; Autoimmune Pancreatitis; Jaundice; Jaundice, Obstructive

Study Results

No Results Posted as of Jul 14, 2020