Autoimmune PancreatitisNCT02797665
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
A study testing corticosteroids and biliary stent in people with Autoimmune Pancreatitis and IgG4-related Sclerosing Cholangitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Pancreatitis, IgG4-related Sclerosing Cholangitis, Obstructive Jaundice
- What is being tested?
- corticosteroids and biliary stent
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults greater than 18 years-old;
- autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
- obstructive jaundice
Who cannot join
- malignancies; active infections;
- pregnancy or breast feeding;
- standard contraindications to ERCP;
- unwillingness or inability to consent for the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Aiming Yang, M.D., +86-10-69151593, yangaiming@medmail.com.cn
About this study
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.
- Being tested
- corticosteroids, biliary stent
- Medical subject headings
- Autoimmune Pancreatitis, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroidsDrug
prednisone 0.6mg/kg/d
biliary stentProcedure or surgery
placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)
| Study group | Role | What they receive |
|---|---|---|
| Steroids group | Active comparator | The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone. Receives: Drug: corticosteroids |
| Stent group | Active comparator | The patients will be treated with oral corticosteroids and biliary stent. Receives: Drug: corticosteroids; Procedure: biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate of obstructive jaundice
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune PancreatitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiming Yang, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797665
- Sponsor's protocol ID
- ZS-844
- Status last verified
- Jul 2020
- First submitted
- 6 Jun 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
- ClinicalTrials.gov ID
- NCT02797665
- Acronym / sponsor ID
- ZS-844
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroids group | Active comparator | Drug: corticosteroidsThe patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone. |
| Stent group | Active comparator | Drug: corticosteroids, Procedure: biliary stentThe patients will be treated with oral corticosteroids and biliary stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults greater than 18 years-old;
- autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
- obstructive jaundice
Key exclusion criteria (4 listed)
- malignancies; active infections;
- pregnancy or breast feeding;
- standard contraindications to ERCP;
- unwillingness or inability to consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corticosteroidsprednisone 0.6mg/kg/d | Drug | Stent group, Steroids group |
| biliary stentplacement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP) | Procedure or surgery | Stent group |
Primary outcome
Clinical remission rate of obstructive jaundice
Time frame: Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiming Yang, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corticosteroids and biliary stent in people with Autoimmune Pancreatitis and IgG4-related Sclerosing Cholangitis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aiming Yang, M.D. (+86-10-69151593, yangaiming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate of obstructive jaundice (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.