Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease

NCT06359496 | Completed DMC

• 1 other identifier: CT2024-ZJU-OBS8
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also . Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial. This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05.

Conditions

Zhejiang University

Keywords

liver transplantation; propensity score matching; split; whole; hepatocellular carcinoma; prognosis

Outcome Measures

Primary Outcomes (2)

• Postoperative complications were evaluated by postoperative imaging reports and serological indicators

  Including rejection, emerging metabolic diseases, infections

  Jan.1 2018-Dec.31 2022

• The survival rate of each group was evaluated by follow-up survey and K-M curve

  Including overall survival rate and/or tumor free survival rate

  Jan.1 2018-Dec.31 2022

Interventions

No intervention factor OTHER

No intervention factor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Each organ donation and transplantation strictly followed the guidelines of the Ethics Committee of the two hospitals, the current regulation of the Chinese Government and the Declaration of Helsinki. Every precaution has been taken to protect the privacy of research subjects and the confidentiality of their personal information. Informed consent was obtained from all patients.

You may qualify if:

• ≥ 18 years old
• Received a liver transplantation between 2018 and 2022 (3) Liver transplantation was performed by SLT or WLT

You may not qualify if:

• Re-LT
• Multiorgan transplantation
• Survival≤one week after LT
• Incomplete data

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Xiao Xu

Hangzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor，PHD，MD

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 11, 2024
• Study Start: February 23, 2024
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE

Locations

CN (1)