Biliary AtresiaCBSPLTNCT02503384
Clinical and Basic Study for Pediatric Liver Transplantation
An observational study of Biliary Atresia and Metabolic Disorders, run by RenJi Hospital at 1 site in China.
Trial summary
Background: In mainland China, the development of pediatric liver transplantation (LT) has lagged behind that of adult LT during the past two decades, but it has been progressing immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric transplant center in mainland China. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Biliary Atresia, Metabolic Disorders, Fulminant Liver Failure
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Sep 2018
- Phase
- Observational
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric liver transplantation cases
Who may be able to join
- Children with end-stage liver diseases
- Children with metabolic disorders for whom liver transplantation are required
- Children with fulminant liver failure
- Children with unresectable hepatic tumors
- Other miscellaneous conditions which need liver transplantation
Who cannot join
- Recipient age ≥ 18 years
- Patients with metastatic liver tumors
- Severe systmatic infections
- Acquired Immune Deficiency Syndrome
Trial locations and contacts
1 site in 1 country.
Zhifeng Xi, MD contact
China1 site, 1 recruiting
- Recruiting
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
Qiang Xia, MD, PhD, xiaqiang@medmail.com.cn
About this study
Background: In mainland China, the development of pediatric liver transplantation (LT) has lagged behind that of adult LT during the past two decades, but it has been progressing immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric transplant center in mainland China.
Aim and method: This study is performed for establishment of key techniques for pediatric LT in mainland China, including the indications and timing for pediatric LT, the criteria for donor selections, living donor LT planning, prevention and treatment for posttransplant complications, long-term follow-up management et al.
Read the detailed description
Outcome measures:
- Annual caseloads of pediatric liver transplantation
- Patient survival: 1-, 3- and 5-year patient survival after liver transplantation
- Graft survival: 1-, 3- and 5-year graft survival after liver transplantation
- Posttransplant complications, such as biliary complications, vascular complications, acute rejections, infections et al.
- Perioperative data, such as duration of operations, postoperative hospital stay et al.
- Clinical data for living donors.
- Medical subject headings
- Biliary Atresia, Metabolic Diseases, Liver Failure, Acute, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Measured: up to 36 months
Graft survival
Measured: up to 36 months
Annual caseload for pediatric liver transplantation
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Xia, MD, PhD, Study chair, Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503384
- Sponsor's protocol ID
- 15411950401
- Acronym
- CBSPLT
- Status last verified
- Jul 2015
- First submitted
- 17 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Basic Study for Pediatric Liver Transplantation
- ClinicalTrials.gov ID
- NCT02503384
- Acronym / sponsor ID
- CBSPLT / 15411950401
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 21 Jul 2015 (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.
Background: In mainland China, the development of pediatric liver transplantation (LT) has lagged behind that of adult LT during the past two decades, but it has been progressing immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric transplant center in mainland China.
Aim and method: This study is performed for establishment of key techniques for pediatric LT in mainland China, including the indications and timing for pediatric LT, the criteria for donor selections, living donor LT planning, prevention and treatment for posttransplant complications, long-term follow-up management et al.
Detailed description
Outcome measures:
- Annual caseloads of pediatric liver transplantation
- Patient survival: 1-, 3- and 5-year patient survival after liver transplantation
- Graft survival: 1-, 3- and 5-year graft survival after liver transplantation
- Posttransplant complications, such as biliary complications, vascular complications, acute rejections, infections et al.
- Perioperative data, such as duration of operations, postoperative hospital stay et al.
- Clinical data for living donors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric liver transplantation cases
Key inclusion criteria (5 listed)
- Children with end-stage liver diseases
- Children with metabolic disorders for whom liver transplantation are required
- Children with fulminant liver failure
- Children with unresectable hepatic tumors
- Other miscellaneous conditions which need liver transplantation
Key exclusion criteria (4 listed)
- Recipient age ≥ 18 years
- Patients with metastatic liver tumors
- Severe systmatic infections
- Acquired Immune Deficiency Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient survival
Time frame: up to 36 months
Graft survival
Time frame: up to 36 months
Annual caseload for pediatric liver transplantation
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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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.
Zhifeng Xi, MD contact
Qiang Xia, MD, PhD study chair
Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia and Metabolic Disorders, run by RenJi 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 5 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 21 Jul 2015. 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 Zhifeng Xi, MD (yyzs_0@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: up to 36 months). The study lists 3 primary outcomes in all. 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 21 Jul 2015.