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Substudy: Interconnection of Arterial Tumor Feeders Through Tumor Sinusoid in HCC

NCT04641637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-01

No results posted yet for this study

Summary

It is postulated that all arterial tumor feeders supplying a HCC tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.

Conditions

Interventions

PROCEDURE

TACE

Through a 7 French sheath placed through a single femoral arterial puncture, a guide catheter (Cobra 1 Guide Catheter, Mach 1, Boston Scientific Corporation, Marlborough, USA) is placed at the coeliac axis. From the digital subtraction angiography (DSA), the number of arterial tumor feeders to the HCC is identified. One or more feeder(s) is to be catheterized for delivery of therapeutic agent using a 2.4 French microcatheter (Merit Maestro, Merit Medical Systems, Utah, USA), and the other feeder(s) is occluded with a balloon catheter using 0.1 to 0.2mL diluted contrast for inflation (4mm x 10mm Temporary Occlusion Balloon Catheter, Occlusafe, Terumo Clinial Supply, Gifu, Japan). The occlusion target could be a feeder or a common trunk leading to a number of feeders. The therapeutic agent was delivered under fluoroscopic control until the vasculature of the whole tumors is entirely filled, which was assessed with DSA and non-contrast CT performed at the completion of the procedure.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Simon Yu, Professor · DIIR, CUHK, Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-02-28
Completion
2023-04-28

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641637 on ClinicalTrials.gov