Prognosis Analysis of Elderly Donor Liver in Liver Transplantation

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Completed

CT.gov ID

NCT05355662

Collaborator

(none)

11,569

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Based on the follow-up data of elderly donation after cardiac death(DCD) donor liver transplant recipients from the CLTR, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation Hepatocellular Carcinoma Survival	Other: Age

Detailed Description

Since the Chinese organ donation system was developed in 2015, donation has been the only source of organs for transplantation in China. Adult patients (age 18 or older) who underwent LT using grafts from deceased donors between January 1st, 2015, and December 31st, 2018, were retrospectively identified using the CLTR, a database and official website for national data gathering. Based on the follow-up data of elderly DCD donor liver transplant recipients from the CLTR, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Study Design

Study Type:

Observational

Actual Enrollment :

11569 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Prognosis Analysis of Elderly Donor Liver From Donation After Cardiac Death in Liver Transplantation: a Multicenter Clinical Study

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
OLDs Older liver donors (OLDs) and recipients were defined as individuals whose donor age was equal to or greater than 60 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.	Other: Age The study was retrospective and did not involve the application of interventions.
ILDs Ideal or young liver donors (ILDs) and recipients were defined as donors aged 18-40 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.	Other: Age The study was retrospective and did not involve the application of interventions.
ALDs Average liver donors (ALDs) and recipients were defined as donor age 40-59 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.	Other: Age The study was retrospective and did not involve the application of interventions.

Arm

Intervention/Treatment

OLDs

Older liver donors (OLDs) and recipients were defined as individuals whose donor age was equal to or greater than 60 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.

Other: Age

The study was retrospective and did not involve the application of interventions.

ILDs

Ideal or young liver donors (ILDs) and recipients were defined as donors aged 18-40 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.

Other: Age

The study was retrospective and did not involve the application of interventions.

ALDs

Average liver donors (ALDs) and recipients were defined as donor age 40-59 years. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and preoperative and postoperative characteristics of the corresponding recipients and donors were collected and recorded for subsequent analysis.

Other: Age

The study was retrospective and did not involve the application of interventions.

Outcome Measures

Primary Outcome Measures

Post-operative survival time [Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.]
Postoperative survival time for patients receiving liver transplantation
Transplanted liver status [Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.The functional status of the transplanted liver was recorded during this period.]
Postoperative Liver Function in Patients Undergoing Liver Transplantation
Recurrence of the primary disease after surgery [The time period between liver transplantation and the initial examination revealing a recurrence of primary disease, or until the end of follow-up on December 31, 2020.whichever came first, assessed up to 72 months.]
Recurrence of primary disease in patients who underwent liver transplantation after surgery

Secondary Outcome Measures

Surgery details [Intraoperative]
Detailed information such as operation time
Post-operative complications in patients who underwent liver transplantation [Time from the end of liver transplantation to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 72 months.During this period, all postoperative complications of the patient will be recorded.]
Specific details of all post-operative complications in patients who underwent liver transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Recipient age ≥ 18 years and < 65 years.
Donor age ≥ 18 years.

Exclusion Criteria:

Recipient age <18 years or ≥65 years.
Donor age <18 years.
Patients who died within 30 days after transplantation.
Secondary liver transplantation.
Multiple organ transplantation.
Patients with incomplete data or failed follow-up.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

Study Chair: Bo Wang, MD PhD, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hu Liangshuo, Principal Investigator, First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT05355662

Other Study ID Numbers:

No. XJTU1AF-CRF-2019-029

First Posted:

May 2, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hu Liangshuo, Principal Investigator, First Affiliated Hospital Xi'an Jiaotong University

elderly donor

liver transplantation

donation after cardiac death

hepatocellular carcinoma

survival

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Study Results

No Results Posted as of May 2, 2022