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

Not Applicable

• Conditions: Liver Neoplasms
• Interventions: Other: PAFA; Other: tumor ablation

• Registration Number: NCT03143140
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-05-22
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Primary Completion: 2018-03-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-17
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAFA and tumor ablation	PAFA	first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor
PAFA and tumor ablation	tumor ablation	first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor
tumor ablation	tumor ablation	ablation of tumor directly

Primary Outcome Measures

Name	Time	Method
completed tumor necrosis	1 month	Contrast enhanced CT or MRI was examed to evaluate tumor necrosis 1 month after ablation.

Secondary Outcome Measures

Name	Time	Method
tumor recurrence	up to 36 months	tumor recurrence around the ablation zone

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China