Home » Trials » SLCTR/2016/023


Effect of trans-arterial chemo embolization therapy on angiogenesis and tumour proliferation in patients with hepatocellular carcinoma -

SLCTR Registration Number

SLCTR/2016/023


Date of Registration

28 Sep 2016

The date of last modification

Sep 30, 2016



Application Summary


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 of Health Condition(s) Studied

Hepatocellular carcinoma


Scientific Acronym

None


Public Acronym

None


Brief title

Angiogenesis and tumour proliferation in hepatocellular carcinoma


Universal Trail Number

None


Any other number(s) assigned to the trial and issuing authority

P213/12/2012 (ERC: Kelaniya)


Trial Details


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


Assignment

Parallel


Purpose

Treatment


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

  1. Portal vein and hepatic vein invasion needing urgent intervention
  2. Allergy to contrast material or doxorubicin


Primary outcome(s)

  1. Degree of cell necrosis

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.

  1. Tumour proliferative index

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.


Primary outcome(s) - Time of assessment(s)

The specimen will be fixed and sent for pathological evaluation immediately following surgical resection


Secondary outcome

Degree of Vascular Endothelial Growth Factor (VEGF) expression in each tumour zone as a surrogate marker for tumour angiogenesis.


Secondary outcome(s) - Time of assessment(s)

Degree of Vascular Endothelial Growth Factor (VEGF) expression in each tumour zone as a surrogate marker for tumour angiogenesis.



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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 12.12.2012 and extended on 12.07.2016 (Ref: P213/12/2012)


Funding source

National Research Council (Grant no: 13/105)



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None