NCT06364839

Brief Summary

Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients. Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 4, 2024

Last Update Submit

April 12, 2024

Conditions

Hepatocellular Carcinoma, Non-cirrhotic Liver

Outcome Measures

Primary Outcomes (3)

  • Postoperative complications were evaluated by postoperative imaging and serological examination

    Including rejection after liver transplantation, vascular complications, new metabolic diseases and so on

    3 months

  • The overall survival rate was evaluated by follow-up investigation and outpatient review

    1-3 years

  • The tumor-free survival rate was evaluated by follow-up investigation and outpatient review

    1-3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Previously registered liver transplant recipients

You may qualify if:

  • liver transplants, performed from January 2015 to December 2020

You may not qualify if:

  • pediatric LT; LT for non-tumor lesions; LT for other malignant tumors (cholangiocarcinoma, carcinoma of gallbladder, mixed carcinoma, and secondary tumors); re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 1 week due to post-operative hemorrhage after LT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiao Xu

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

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

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 15, 2024

Study Start

February 20, 2024

Primary Completion

March 23, 2024

Study Completion

March 25, 2024

Last Updated

April 15, 2024

Record last verified: 2024-04

Locations

CN(1)