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Clinical and Basic Study for Pediatric Liver Transplantation (CBSPLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02503384
Recruitment Status : Unknown
Verified July 2015 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Biliary Atresia Metabolic Disorders Fulminant Liver Failure Hepatic Tumors

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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Basic Study for Pediatric Liver Transplantation
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Patient survival [ Time Frame: up to 36 months ]
  2. Graft survival [ Time Frame: up to 36 months ]
  3. Annual caseload for pediatric liver transplantation [ Time Frame: up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric liver transplantation cases
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503384


Contacts
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Contact: Zhifeng Xi, MD yyzs_0@126.com

Locations
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China
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, China, 200127
Contact: Qiang Xia, MD, PhD       xiaqiang@medmail.com.cn   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Qiang Xia, MD, PhD Department of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02503384    
Other Study ID Numbers: 15411950401
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Liver Neoplasms
Liver Failure
Biliary Atresia
Liver Failure, Acute
Metabolic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Abnormalities
Congenital Abnormalities
Digestive System Neoplasms
Neoplasms by Site
Neoplasms