ClinicalTrials.gg
Status unknownNCT02797665Updated Jul 14, 2020

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

An interventional study of corticosteroids and biliary stent in Autoimmune Pancreatitis, IgG4-related Sclerosing Cholangitis and Obstructive Jaundice, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autoimmune Pancreatitis
  • IgG4-related Sclerosing Cholangitis
  • Obstructive Jaundice
03

In context

Autoimmune Pancreatitis

28 studies on the registry are indexed under Autoimmune Pancreatitis; 7 are open to participants now.

Browse Autoimmune Pancreatitis studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • ; active infections;
  • pregnancy or breast feeding;
  • standard to ERCP;
  • unwillingness or inability to consent for the study
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Steroids group

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

    Drug: corticosteroids

  • Active comparator
    Stent group

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

    Drug: corticosteroids · Procedure: biliary stent

Interventions

  • Drugcorticosteroids

    prednisone 0.6mg/kg/d

  • Procedurebiliary stent

    placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)

06

What researchers measure

Primary outcomes

  1. Clinical remission rate of obstructive jaundice

    Time frame: Day 60

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2016, a primary completion of Dec 2021 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2016
First posted
Jun 13, 2016
Start
May 2016
Primary completionEst.
Dec 2021
CompletionEst.
Dec 2021
Last update
Jul 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02797665
Responsible party
Sponsor
First posted
Jun 13, 2016
Start date
May 2016
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jul 14, 2020

Study contacts

Aiming Yang, M.D.
Contact
yangaiming@medmail.com.cn
+86-10-69151593
Aiming Yang, M.D.
principal investigator · Peking Union Medical College Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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