Prediction of Early Recovery of Liver Function After LDLT in Children: An Ambispective Cohort Study

Prediction of Early Recovery of Liver Function After Living Donor Liver Transplantation in Children: An Ambispective Cohort Study

The investigators included children with living donor liver transplantation (LDLT) from January 1, 2018 to July 31, 2022 as a retrospective cohort, and the group from August 1, 2022 to June 30, 2023 as a prospective cohort. The investigators collected the demographic and clinicopathological data of donors and recipients, and determined the risk factors of early postoperative delayed recovery of hepatic function (DRHF) by univariate and multivariate Logical regression analyses.

Study Overview

• Status: Completed
• Conditions: Liver and Biliary Tract Disorders in Duration of Pregnancy; Other End-stage Liver Diseases in Children

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Children's Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigators included children who underwent LDLT in this center from January 1, 2018 to June 30, 2023.

Description

Inclusion Criteria:

1. children with the indication of LDLT [cholestatic liver disease (such as BA), metabolic liver disease (such as Wilson's disease and Ornithine transcarbamylase deficiency), acute liver failure (such as drug induced), neoplastic disease (such as hepatoblastoma), vascular disease (such as cavernous transformation of portal vein and congenital absence of portal vein), re-transplantation and others];
2. the relatives of the children voluntarily donated part of the liver which met the requirements of LDLT.

Exclusion Criteria:

1. recipients with contraindications of LDLT (such as coagulation dysfunction, acute infection, cardiopulmonary failure);
2. failure to complete LDLT due to various reasons (such as death during or within 3 days after operation);
3. recipients or donors with incomplete necessary data.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
living donor liver transplantation in children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DRHF	Investigators collected liver function data of children after LDLT. Delayed recovery of hepatic function (DRHF) is characterized by the increase of PT-INR combined with hyperbilirubinemia on or after postoperative day 5.	30 days after LDLT in children

Collaborators and Investigators

• Sponsor: Huiwu Xing

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 9, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease; Biliary Tract Diseases
• Other Study ID Numbers: DRHFafterLDLT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No