A Study on the Angioarchitecture of Hepatocellular Carcinoma

Not Applicable

Terminated

• Conditions: Carcinoma, Hepatocellular
• Interventions: Other: embolization

• Registration Number: NCT03808766
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Hong Kong as well as globally. Transarterial therapy has been playing an important role in the treatment algorithm for patients with HCC. The primary purpose of transarterial therapy is eradication of the viability of the targeted tumors. The treatment outcomes have been variable among the various treatments, in general, there is still much room for improvement, especially for large size tumors. From the studies on Transarterial chemoembolization (TACE), it is known that the treatment outcome is affected by the nature and the formulation of therapeutic agents that are delivered, which is related to the angioarchitecture of the tumor. Knowledge on the angioarchitecture of HCC is essential for the understanding of the requirements for effective transarterial treatment of HCC. This prospective study is aimed to study the angioarchitecture of HCC.

Detailed Description

Embolization is performed within 2 weeks before the scheduled date of partial hepatectomy. The purpose of the timing is two folded, it allows observation of the embolization effect to be differentiated among the various embolic agents, it also allows time for the patient and the liver to recover from the embolization.

The patient then receives partial hepatectomy within 2 weeks unless the result of liver function tests shows contraindication to surgery, in which case the liver function test is further evaluated on a weekly basis until the findings are acceptable, and surgery is scheduled accordingly.

Study Timeline

• Study Start: 2018-08-13
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Status Verified: 2023-04
• Primary Completion: 2023-04-17
• Study Completion: 2023-04-17
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age above 18 years
2. HCC suitable for partial hepatectomy
3. Child-Pugh A or B cirrhosis
4. Eastern Cooperative Oncology Group performance score 0 or 1
5. Barcelona clinic liver cancer (BCLC) staging A or B
6. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
7. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)

Exclusion Criteria

1. Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
2. Evidence of tumor invasion of portal vein or hepatic vein
3. History of acute tumor rupture presenting with hemo-peritoneum
4. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
5. Serum creatinine level > 150umol/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tumor >3cm to 7cm	embolization	Embolization with particulate or liquid embolic agent
Tumor > 7cm	embolization	Embolization with particulate or liquid embolic agent
Tumor <=3cm	embolization	Embolization with particulate or liquid embolic agent

Primary Outcome Measures

Name	Time	Method
arterial flow through the tumor	within one hour	Digital subtraction angiography (DSA) is performed before and after embolization, through catheterization of the arterial branches supplying the tumor, images from arterial phase to delayed phase are captured. Contrast distribution at the arterial tumor branches, arterioles, tumor sinusoids, peri-tumoral liver, and peri-tumoral portal venules are observed.

Secondary Outcome Measures

Name	Time	Method
The degree of tumor necrosis	within 2 weeks after embolization	The percentage of viable residual HCC is assessed quantitatively in increments of 5 %, with the measurement of the largest axial diameter of viable HCC compared to that of the whole tumor using a microscopic ruler.

Trial Locations

Locations (1)

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong