PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

Tanta University

Status: Enrolling

Conditions: Hepato Cellular Carcinoma (HCC); Portal Vein Tumour Thrombosis

Treatments: Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II)

Study type: Observational

Funder types: Other

Identifiers

NCT06960954

36264PR1127/3/25

Details and patient eligibility

About

The goal of this cross-sectional observational study is to evaluate the relation between Prothrombin induced by vitamin K absence II (PIVKA-II) and the presence of portal vein tumor thrombosis (PVTT) in hepatocellular carcinoma (HCC) patients.

Researchers will compare PIVKA-II serum levels in HCC patients with PVTT and without PVTT.

Participants will undergo history-taking, clinical examination, laboratory investigations, PIVKA-II serum level, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, and Triphasic CT abdomen with contrast or MRI to evaluate tumor site, size, number, and presence of PVTT (a filling defect in the portal vein or its branch to distinguish PVTT or thrombus).

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients older than 18 years.
• Patients with confirmed HCC with or without PVTT (Diagnosed by two imaging modalities or one imaging modality with elevated serum alpha fetoprotein or liver biopsy).

Exclusion criteria

• Prior locoregional therapy or liver transplantation.
• Patients on vitamin K, vitamin K antagonists or antibiotics.
• Patients with cholestasis.
• Patients with renal insufficiency.
• Patients with other malignancies.
• Unwilling to participate in our study.

Trial design

116 participants in 2 patient groups

HCC patients with PVTT.

Description:

58 HCC patients with PVTT.

Treatment:

Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II)

HCC Patients without PVTT.

Description:

58 HCC Patients without PVTT.

Treatment:

Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II)