Clinical and Basic Study for Pediatric Liver Transplantation (CBSPLT)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Zhifeng Xi, MD; Email: yyzs_0@126.com

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
    • Contact: Qiang Xia, MD, PhD; Email: xiaqiang@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric liver transplantation cases

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Qiang Xia, MD, PhD, Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Neoplasms; Neoplasms by Site; Congenital Abnormalities; Digestive System Neoplasms; Liver Diseases; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Liver Failure; Liver Neoplasms; Metabolic Diseases; Liver Failure, Acute; Biliary Atresia
• Other Study ID Numbers: 15411950401