NCT02797665

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

5.6 years

First QC Date

June 6, 2016

Last Update Submit

July 12, 2020

Conditions

Autoimmune PancreatitisIgG4-related Sclerosing CholangitisObstructive Jaundice

Outcome Measures

Primary Outcomes (1)

  • Clinical remission rate of obstructive jaundice

    Day 60

Study Arms (2)

Steroids group

ACTIVE COMPARATOR

The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.

Drug: corticosteroids

Stent group

ACTIVE COMPARATOR

The patients will be treated with oral corticosteroids and biliary stent.

Drug: corticosteroidsProcedure: biliary stent

Interventions

corticosteroidsDRUG

prednisone 0.6mg/kg/d

Stent groupSteroids group
biliary stentPROCEDURE

placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)

Stent group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults greater than 18 years-old;
  • autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
  • obstructive jaundice

You may not qualify if:

  • malignancies; active infections;
  • pregnancy or breast feeding;
  • standard contraindications to ERCP;
  • unwillingness or inability to consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Autoimmune PancreatitisJaundice, Obstructive

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Pancreatitis, ChronicPancreatitisPancreatic DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsJaundiceHyperbilirubinemiaSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Aiming Yang, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiming Yang, M.D.

CONTACT

+86-10-69151593yangaiming@medmail.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 13, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

CN(1)