The Effect of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma
Overview
To evaluate a novel technique-ultrasound guided percutaneous abaltion of tumor feeding artery before RFA for liver malignancy.
Full Title of Study: “The Clinical Value of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: March 31, 2018
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.
Interventions
- Other: PAFA
- percutaneous ablation of tumor feeding artery
- Other: tumor ablation
- ablation of tumor area directly
Arms, Groups and Cohorts
- Experimental: PAFA and tumor ablation
- first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor
- Other: tumor ablation
- ablation of tumor directly
Clinical Trial Outcome Measures
Primary Measures
- completed tumor necrosis
- Time Frame: 1 month
- Contrast enhanced CT or MRI was examed to evaluate tumor necrosis 1 month after ablation.
Secondary Measures
- tumor recurrence
- Time Frame: up to 36 months
- tumor recurrence around the ablation zone
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Provider of Information About this Clinical Study
- Principal Investigator: Kun Yan, Director of ultrasonography department – Peking University Cancer Hospital & Institute
- Overall Official(s)
- Kun Yan, master, Study Director, Peking University Cancer Hospital & Institute
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