Clinical and Basic Study for Pediatric Liver Transplantation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02503384

Acronym

CBSPLT

Enrollment

180

Registered

2015-07-21

Start date

2015-07-31

Completion date

2018-09-30

Last updated

2015-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia, Fulminant Liver Failure, Hepatic Tumors, Metabolic Disorders

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Patient survival	up to 36 months
Graft survival	up to 36 months
Annual caseload for pediatric liver transplantation	up to 36 months

Countries

China

Contacts

Primary ContactZhifeng Xi, MD

yyzs_0@126.com

Outcome results