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NCT05907772 Clinical Trial

Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma

Cancer of Liver Clinical Trial

Official title:
Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma: A Multi-center Retrospective Cohort Study in China

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05907772
Other study ID # CT2023-ZJU-OBS1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 27, 2022
Est. completion date November 10, 2022

Study information
Verified date June 2023
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multi-center study in China to investigate the role of PIVKA-II in HCC recipient selection and prognostic stratification by analyzing the data of 522 recipients with HCC registered in the China Liver Transplant Registry.

Recruitment information / eligibility
Status Completed
Enrollment 522
Est. completion date November 10, 2022
Est. primary completion date October 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The HCC patients received LT with pre-operative PIVKA-II records performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR. Exclusion Criteria: - (1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
China Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival the overall survival of liver transplant recipient with HCC January 2015 to December 2020
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