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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC patients with PVTT. | 58 HCC patients with PVTT. |
| |
| HCC Patients without PVTT. | 58 HCC Patients without PVTT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania M Elkafoury, MD | Contact | +201004672358 | rania.elkafoury@med.tanta.edu.eg | |
| Nabila A Elgazzar, MD | Contact | 00201288585733 | nabilaelgazzar@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rania M Elkafoury, MD | Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbyea | 31516 | Egypt |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |