Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

NCT ID: NCT04780802

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-09-30

Brief Summary

To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.

Detailed Description

Transcatheter arterial chemoembolization (TACE) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions of hepatocellular carcinoma (HCC) not eligible for surgical resection, transplantation, or local ablative therapy. The use of balloon assisted TACE has been proposed recently and it could be one of the possible ways to improve the effectiveness of drug delivery to the target tumor and therefore leading to improved treatment outcome.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ballloon catheter

Balloon-assisted transarterial therapy will be performed in the first treatment session only

Group Type: OTHER

The balloon catheter is placed at the various arterial feeders of the tumor

Intervention Type: PROCEDURE

use of a balloon catheter for providing balloon occlusion, in addition to the standard microcatheter for drug delivery, both catheters are to be placed in parallel through a single guide catheter. Only one arterial puncture wound is involved. The inflated balloon provides temporary occlusion of all arterial tumor feeders except for the one which is selectively catheterized with a microcatheter for delivery of the therapeutic agent. The therapeutic agent consists of Lipiodol mixed with a chemotherapeutic drug, it is delivered through the microcatheter under fluoroscopic control.

Interventions

The balloon catheter is placed at the various arterial feeders of the tumor

use of a balloon catheter for providing balloon occlusion, in addition to the standard microcatheter for drug delivery, both catheters are to be placed in parallel through a single guide catheter. Only one arterial puncture wound is involved. The inflated balloon provides temporary occlusion of all arterial tumor feeders except for the one which is selectively catheterized with a microcatheter for delivery of the therapeutic agent. The therapeutic agent consists of Lipiodol mixed with a chemotherapeutic drug, it is delivered through the microcatheter under fluoroscopic control.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients of age above 18 years

2. Patients who are indicated for transarterial treatment for HCC

3. Child-Pugh A or B cirrhosis

4. Eastern Cooperative Oncology Group performance score 0 or 1

5. BCLC A or B

6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),

7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.

8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.

9. No invasion of portal vein or hepatic vein

10. 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)

11. Total tumor mass < 50% liver volume

12. Size of any individual tumor <= 7cm in largest dimension

13. Serum creatinine < 130 umol/L or Creatinine clearance > 55 ml/min.

Exclusion Criteria

1. Concurrent ischemic heart disease or heart failure

2. History of asthma, chronic obstructive airway disease or respiratory decompensation.

3. History of acute tumor rupture presenting with hemo-peritoneum

4. Biliary obstruction not amenable to percutaneous or endoscopic drainage

5. Child-Pugh C cirrhosis

6. History of hepatic encephalopathy

7. Intractable ascites not controllable by medical therapy

8. History of variceal bleeding within last 3 months

9. Serum total bilirubin level > 50 umol/L

10. Serum albumin level < 26 g/L

11. INR > 1.3

12. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)

13. Arterio-portal venous shunt affecting >1 hepatic segment on CT

14. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Yu, Professor

Role: PRINCIPAL_INVESTIGATOR

DIIR, CUHK, Hong Kong

Locations

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

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

VIR-20-13

Identifier Type: -

Identifier Source: org_study_id