PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

NCT06960954 | Recruiting

• 1 other identifier: 36264PR1127/3/25
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hepato Cellular Carcinoma (HCC); Portal Vein Tumour Thrombosis

Keywords

PIVKA-II; Portal vein tumor thrombosis; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• PIVKA-II serum level for prediction of PVTT in HCC patients.

  PIVKA-II level (mAU/mL) will be measured in serum of HCC patients with and without PVTT.

  through study completion, an average of 1 year

Study Arms (2)

HCC patients with PVTT.

58 HCC patients with PVTT.

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

HCC Patients without PVTT.

58 HCC Patients without PVTT.

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

Interventions

Prothrombin induced by vitamin K absence II (PIVKA-II) DIAGNOSTIC_TEST

Serum PIVKA-II level will be measured in HCC patients with and without PVTT.

HCC Patients without PVTT.; HCC patients with PVTT.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional study will be carried out on 116 patients attending the Tanta Tropical Medicine Outpatient Clinic, Faculty of Medicine. The start of the research will be in January 2025 to December 2025 or until the collection of the cases.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Rania M Elkafoury, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  STUDY DIRECTOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Nabila A Elgazzar, MD

CONTACT

00201288585733; nabilaelgazzar@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical medicine

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: January 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

EG (1)