Angiogenesis and tumour proliferation in hepatocellular carcinoma after trans-arterial therapy
Phase 3
- Conditions
- Hepatocellular carcinoma
- Registration Number
- SLCTR/2016/023
- Lead Sponsor
- Department of Surgery, Faculty of Medicine, University of Kelaniya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Patients diagnosed with resectable hepatocellular carcinoma (tumour less than 5cm as determined by contrast enhanced CT scan) indicated for surgery
Exclusion Criteria
1. Portal vein and hepatic vein invasion needing urgent intervention
2. Allergy to contrast material or doxorubicin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Degree of cell necrosis <br><br>The specimen will be stained with haematoxylin and eosin. Each zone will be assessed by two different pathologists experienced in reporting liver specimens. The degree of cell death will be examined under the light microscope. The absolute degree of cell death will be given as a percentage figure after examining 10 high power fields. When there is more than 5% difference between the pathologists the slides will be re-evaluated and a common figure will be agreed upon on the degree of cell death. The degree of cell death will be documented in each intra tumour zones and peritumour zones.<br><br>2. Tumour proliferative index<br><br>After the staining with KI 67 the specimens will be examined under the light microscope. 10 high power fields will be examined. The percentage of KI 67 positive cells will be documented as proliferative index.<br> [The specimen will be fixed and sent for pathological evaluation immediately following surgical resection]<br>
- Secondary Outcome Measures
Name Time Method Degree of Vascular Endothelial Growth Factor (VEGF) expression in each tumour zone as a surrogate marker for tumour angiogenesis. [At baseline and 6 weeks following TACE]<br>