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The Effect of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma

P

Peking University Cancer Hospital & Institute

Status

Unknown

Conditions

Liver Neoplasms

Treatments

Other: PAFA
Other: tumor ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT03143140
Z151100004015186

Details and patient eligibility

About

To evaluate a novel technique-ultrasound guided percutaneous abaltion of tumor feeding artery before RFA for liver malignancy.

Full description

Hepatocellular carcinoma is one of the most common tumor in clinical practice. In recent years, various local therapies, especially radiofrequency ablation (RFA) has been proved safe and effective.The main limitation of RFA is that its therapeutic impact is significant compromised by blood flow cooling effect, especially in hypervascular HCC. Recent studies showed combined therapy of TACE and RFA can decrease the blood supply of tumor, increase ablated volume and therefore improve the outcome. However, TACE application is limited in patients who cannot tolerate this therapy due to the side effects of repeated TACE, poor liver function or previously legated hepatic artery. The present study is focus on "difficult-to-treat" HCC patients who are neither surgical candidates, nor TACE candidates. The investigators introduce the novel treatment mode that RFA followed ultrasound guided percutaneous ablation of tumur feeding arterial to treat these difficult cases and evaluate the clinical effect.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. tumor number ≤3, maximum tumor size ≤5cm;
  2. accessibility of tumors via a percutaneous approach;
  3. tumor feeding artery can be detected by 3D contrast enhance ultrasound;
  4. platelet count ≥ 50,000/ml and INR <1.6;
  5. life expectancy more than 6 months
  6. Child grade A or B

Exclusion criteria

  1. patients who scheduled liver transplantation
  2. with extrahepatic metastasis
  3. women during menstruation, pregnancy, child birth and baby nursing period
  4. patients with severe mental disorder
  5. cardiopulmonary failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

PAFA and tumor ablation
Experimental group
Description:
first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor
Treatment:
Other: PAFA
Other: tumor ablation
tumor ablation
Other group
Description:
ablation of tumor directly
Treatment:
Other: tumor ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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