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

Completed

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

• Registration Number: NCT06045949
• Lead Sponsor: Huiwu Xing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-31
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Study First Submitted: 2023-09-09
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DRHF	30 days after LDLT in children	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.

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China