Clinical and Basic Study for Pediatric Liver Transplantation

NCT02503384 | Unknown

• 1 other identifier: 15411950401
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Patient survival

  up to 36 months

• Graft survival

  up to 36 months

• Annual caseload for pediatric liver transplantation

  up to 36 months

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric liver transplantation cases

You may qualify if:

• 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

You may not qualify if:

• Recipient age ≥ 18 years
• Patients with metastatic liver tumors
• Severe systmatic infections
• Acquired Immune Deficiency Syndrome

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Biliary Atresia; Metabolic Diseases; Liver Failure, Acute; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Qiang Xia, MD, PhD

  Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Zhifeng Xi, MD

CONTACT

yyzs_0@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

CN (1)