CClinicalTrials.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has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.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

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • malignancies; active infections;
  • pregnancy or breast feeding;
  • standard contraindications to ERCP;
  • unwillingness or inability to consent for the study
04

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)

05

What researchers measure

Primary outcomes

  1. Clinical remission rate of obstructive jaundice

    Time frame: Day 60

06

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
07

Registry details

Key details

Study ID
NCT02797665
Lead sponsor
Peking Union Medical College Hospital
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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