Back to resultsA Study on the Angioarchitecture of Hepatocellular Carcinoma
Primary Purpose
Carcinoma, Hepatocellular
Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
embolization
Sponsored by
About this trial
This is an interventional other trial for Carcinoma, Hepatocellular
Eligibility Criteria
Inclusion Criteria:
- Age above 18 years
- HCC suitable for partial hepatectomy
- Child-Pugh A or B cirrhosis
- Eastern Cooperative Oncology Group performance score 0 or 1
- Barcelona clinic liver cancer (BCLC) staging A or B
- HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
- 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:
- Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
- Evidence of tumor invasion of portal vein or hepatic vein
- History of acute tumor rupture presenting with hemo-peritoneum
- Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
- Serum creatinine level > 150umol/L
Sites / Locations
- Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Tumor <=3cm
Tumor >3cm to 7cm
Tumor > 7cm
Arm Description
Embolization with particulate or liquid embolic agent
Embolization with particulate or liquid embolic agent
Embolization with particulate or liquid embolic agent
Outcomes
Primary Outcome Measures
arterial flow through the tumor
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
The degree of tumor necrosis
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.
Full Information
NCT ID
NCT03808766
First Posted
October 10, 2018
Last Updated
April 28, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03808766
Brief Title
A Study on the Angioarchitecture of Hepatocellular Carcinoma
Official Title
A Study on the Angioarchitecture of Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Poor patient accrual
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Tumors are categorized into 3 groups based on the longest diameter of the largest tumor:
Group 1: ≤3cm Group 2: >3cm to 7cm Group 3: >7cm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tumor <=3cm
Arm Type
Other
Arm Description
Embolization with particulate or liquid embolic agent
Arm Title
Tumor >3cm to 7cm
Arm Type
Other
Arm Description
Embolization with particulate or liquid embolic agent
Arm Title
Tumor > 7cm
Arm Type
Other
Arm Description
Embolization with particulate or liquid embolic agent
Intervention Type
Other
Intervention Name(s)
embolization
Intervention Description
Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.
Primary Outcome Measure Information:
Title
arterial flow through the tumor
Description
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.
Time Frame
within one hour
Secondary Outcome Measure Information:
Title
The degree of tumor necrosis
Description
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.
Time Frame
within 2 weeks after embolization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age above 18 years
HCC suitable for partial hepatectomy
Child-Pugh A or B cirrhosis
Eastern Cooperative Oncology Group performance score 0 or 1
Barcelona clinic liver cancer (BCLC) staging A or B
HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
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:
Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
Evidence of tumor invasion of portal vein or hepatic vein
History of acute tumor rupture presenting with hemo-peritoneum
Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
Serum creatinine level > 150umol/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Yu
Organizational Affiliation
DIIR, CUHK, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study on the Angioarchitecture of Hepatocellular Carcinoma
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