NCT06925828

Brief Summary

The feasibility of split liver transplantation (SLT) remains controversial. This study aimed to evaluate the outcomes of SLT in adult recipients and to identify specific areas of improvements. A retrospective analysis was conducted on adults who underwent full size SLT between January 2021 and December 2023. The short-term outcomes of these patients who underwent SLT were compared with those of patients who underwent whole liver transplantation (WLT) during the same period.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

April 7, 2025

Last Update Submit

April 7, 2025

Conditions

Liver Transplantation

Keywords

Split liver transplantationWhole liver transplantationShort-term OutcomesSurgical complicationsMorbidity and Mortality

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    the overall survival of liver transplant recipient during study period

    2021.01.01-2025.12.31

Secondary Outcomes (1)

  • Postoperative complications

    2021.01.01-2025.12.31

Study Arms (2)

SLT group

Adult recipients who underwent split liver transplantation

Other: No intervention

WLT group

Adult recipients who underwent whole liver transplantation

Other: No intervention

Interventions

No interventionOTHER

No intervention

SLT groupWLT group

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult recipients who underwent SLT or WLT

You may qualify if:

  • For the donor graft:
  • age of 18-60 years;
  • BMI of 19-28 kg/m2;
  • hemodynamic stability or use of a single vasoactive drug with a small dosage (norepinephrine ≤ 0.1 μg/kg/min or dopamine ≤ 5 μg/kg/min);
  • liver steatosis ≤ 10%;
  • liver functional indicators (ALT, AST, total bilirubin quantification) ≤ 3 times the normal value;
  • blood sodium ≤ 160 mmol/L;
  • For the SLT recipients
  • Patients who had registered in the China Organ Transplant Response Systems.
  • Initial liver transplantation.
  • Graft-to-Recipient Weight Ratio (GRWR) ≥ 1%.

You may not qualify if:

  • For the donor graft
  • uncontrollable infection
  • significant vascular and biliary variation.
  • For the recipients
  • Severe portal hypertension.
  • Significant vascular variation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo Medical Centre Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 13, 2025

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)