Home » Trials » SLCTR/2016/023
Effect of trans-arterial chemo embolization therapy on angiogenesis and tumour proliferation in patients with hepatocellular carcinoma
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SLCTR Registration Number
SLCTR/2016/023
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of trans-arterial chemo embolization therapy on angiogenesis and tumour proliferation in patients with hepatocellular carcinoma
Public Title of Trial
Angiogenesis and tumour proliferation in hepatocellular carcinoma after trans-arterial therapy
Disease or Health Condition(s) Studied
Hepatocellular carcinoma
Scientific Acronym
None
Public Acronym
None
Brief title
Angiogenesis and tumour proliferation in hepatocellular carcinoma
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P213/12/2012 (ERC: Kelaniya)
What is the research question being addressed?
What is the effect of trans-arterial chemo embolization therapy on angiogenesis and tumour proliferation in patients with hepatocellular carcinoma?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Patients presenting to the North Colombo Teaching Hospital and have resectable small (smaller than 5cm) HCC will be randomly allocated into 2 groups.
Based on patients’ liver functions and the contrast enhanced CT scan appearance (residual liver volume and the anatomical status of the liver) decision to operate will be taken in a multi-disciplinary meeting. The intervention arm will receive trans-arterial chemo embolization (TACE) 6 weeks before the surgery. The control arm will undergo surgery without TACE.
Inclusion criteria
Patients diagnosed with resectable hepatocellular carcinoma (tumour less than 5cm as determined by contrast enhanced CT scan) indicated for surgery
Exclusion criteria
Primary outcome(s)
|
1.
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.
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. |
[ The specimen will be fixed and sent for pathological evaluation immediately following surgical resection ] |
Secondary outcome(s)
|
1.
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 ] |
Target number/sample size
30 (15 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-09-28
Anticipated end date
2018-02-28
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Research Council (Grant no: 13/105)
Regulatory approvals
Status
Approved
Date of Approval
2016-07-12
Approval number
P213/12/2012
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Rohan C Siriwardana
Consultant Hepatobiliary Surgeon
Department of Surgery, Faculty of Medicine, University of Kelaniya.
Tel: 0775544015
Mob: 0777250213
rohansiriwardana@yahoo.com
Contact Person for Public Queries
Dr. Rohan C Siriwardana
Consultant Hepatobiliary Surgeon
Department of Surgery, Faculty of Medicine, University of Kelaniya.
Tel: 0775544015
Mob: 0777250213
rohansiriwardana@yahoo.com
Primary study sponsor/organization
Department of Surgery, Faculty of Medicine, University of Kelaniya
PO Box 6, Thalagolla Road, Ragama,
GQ 11010, Sri Lanka
Tel: +94112956993
Email: info.med@kln.ac.lk
http://www.kln.ac.lk/medicine/depts/surgery/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
