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Assessment of AFP and PIVKA-I...

Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2028-04-01

Brief Summary

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As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC.

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Detailed Description

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Conditions

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Liver Transplantation Hepatocellular Carcinoma Alpha-Fetoprotein Protein Induced by Vitamin K Absence or Antagonist-II

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preoperative AFP < 400 ng/mL or PIVKA-II < 200mAU/mL

No interventions assigned to this group

Preoperative AFP ≥ 400 ng/mL and PIVKA-II ≥ 200mAU/mL

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
2. Patients undergoing deceased donor liver transplantation for the first time.

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, (5) taking warfarin at the time of LT biomarker measurements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers