Clinical and Basic Study for Pediatric Liver Transplantation

• Conditions: Biliary Atresia; Metabolic Disorders; Hepatic Tumors; Fulminant Liver Failure

• Registration Number: NCT02503384
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-17
• Last Update Submitted: 2015-07-17
• Study First Posted: 2015-07-21
• Last Update Posted: 2015-07-21
• Primary Completion: 2018-07
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient survival	up to 36 months
Graft survival	up to 36 months
Annual caseload for pediatric liver transplantation	up to 36 months

Trial Locations

Locations (1)

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China