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

Sponsor

Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT05907772

Collaborator

(none)

522

Enrollment

Location

2.5

Actual Duration (Months)

211.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Liver	Other: No intervention

Study Design

Study Type:

Observational

Actual Enrollment :

522 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Aug 27, 2022

Actual Primary Completion Date :

Oct 25, 2022

Actual Study Completion Date :

Nov 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Recipients with preoperative PIVKA-II≤240mAU/mL	Other: No intervention No intervention
Recipients with preoperative PIVKA-II>240mAU/mL	Other: No intervention No intervention

Arm

Intervention/Treatment

Recipients with preoperative PIVKA-II≤240mAU/mL

Other: No intervention

No intervention

Recipients with preoperative PIVKA-II>240mAU/mL

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

Overall survival [January 2015 to December 2020]
the overall survival of liver transplant recipient with HCC

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiao Xu, Professor, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05907772

Other Study ID Numbers:

CT2023-ZJU-OBS1

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

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:

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Liver Neoplasms

Study Results

No Results Posted as of Jun 18, 2023