Status:
COMPLETED
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 (HC...
Eligibility Criteria
Inclusion
- Patients of age above 18 years
- Patients who are indicated for transarterial treatment for HCC
- Child-Pugh A or B cirrhosis
- Eastern Cooperative Oncology Group performance score 0 or 1
- BCLC A or B
- No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
- HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
- No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
- No invasion of portal vein or hepatic vein
- 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)
- Total tumor mass \< 50% liver volume
- Size of any individual tumor \<= 7cm in largest dimension
- Serum creatinine \< 130 umol/L or Creatinine clearance \> 55 ml/min.
Exclusion
- Concurrent ischemic heart disease or heart failure
- History of asthma, chronic obstructive airway disease or respiratory decompensation.
- History of acute tumor rupture presenting with hemo-peritoneum
- Biliary obstruction not amenable to percutaneous or endoscopic drainage
- Child-Pugh C cirrhosis
- History of hepatic encephalopathy
- Intractable ascites not controllable by medical therapy
- History of variceal bleeding within last 3 months
- Serum total bilirubin level \> 50 umol/L
- Serum albumin level \< 26 g/L
- INR \> 1.3
- Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
- Arterio-portal venous shunt affecting \>1 hepatic segment on CT
- Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04780802
Start Date
May 1 2022
End Date
September 30 2022
Last Update
October 21 2022
Active Locations (1)
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1
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong