Clinical and Basic Study for Pediatric Liver Transplantation

NCT ID: NCT02503384

Last Updated: 2015-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Biliary Atresia Metabolic Disorders Fulminant Liver Failure Hepatic Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Recipient age ≥ 18 years
* Patients with metastatic liver tumors
* Severe systmatic infections
* Acquired Immune Deficiency Syndrome
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Qiang Xia, MD, PhD

Role: STUDY_CHAIR

Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhifeng Xi, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Qiang Xia, MD, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15411950401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Angiotensin II in Liver Transplantation
NCT04901169 RECRUITING PHASE2/PHASE3