Clinical and Basic Study for Pediatric Liver Transplantation

Biliary Atresia Clinical Trial

— CBSPLT  

Official title:

Clinical and Basic Study for Pediatric Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02503384
• Other study ID #: 15411950401
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2015
• Last updated: July 17, 2015
• Start date: July 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2015
• Source: RenJi Hospital
• Contact: Zhifeng Xi, MD
• Email: yyzs_0[@]126.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Biliary Atresia
• Fulminant Liver Failure
• Hepatic Tumors
• Liver Failure
• Liver Failure, Acute
• Liver Neoplasms
• Metabolic Diseases
• Metabolic Disorders

Locations

Country	Name	City	State
China	Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival		up to 36 months	No
Primary	Graft survival		up to 36 months	No
Primary	Annual caseload for pediatric liver transplantation		up to 36 months	No