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Clinical and Basic Study for Pediatric Liver Transplantation (CBSPLT)

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Hepatic Tumors
Fulminant Liver Failure
Metabolic Disorders
Biliary Atresia

Study type

Observational

Funder types

Other

Identifiers

NCT02503384
15411950401

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

1 month to 17 years old

Volunteers

No 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

Trial contacts and locations

1

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Central trial contact

Zhifeng Xi, MD

Data sourced from clinicaltrials.gov

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