Hepatocellular Carcinoma
Conditions
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.
Interventions
PROCEDUREThe 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in hemodynamics of arterial blood supply to HCC tumors | immediately after completion of procedure | The change in number of feeding arteries |
| The change in the perfusion pattern of HCC tumors | immediately after completion of procedure | The change in perfusion pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Hong Kong
Outcome results
None listed