Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: The balloon catheter is placed at the various arterial feeders of the tumor

• Registration Number: NCT04780802
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Status Verified: 2022-03
• Study Start: 2022-05-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ballloon catheter	The balloon catheter is placed at the various arterial feeders of the tumor	Balloon-assisted transarterial therapy will be performed in the first treatment session only

Primary Outcome Measures

Name	Time	Method
The change in the perfusion pattern of HCC tumors	immediately after completion of procedure	The change in perfusion pressure.
The change in hemodynamics of arterial blood supply to HCC tumors	immediately after completion of procedure	The change in number of feeding arteries

Secondary Outcome Measures

Name	Time	Method
Tumor response	3 months	Tumor response by CT such as complete response according to European Association for the Study of the Liver (EASL) necrosis guidelines.

Trial Locations

Locations (1)

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