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

The Clinical Value of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma

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

Study Overview

• Status: Unknown
• Conditions: Liver Neoplasms
• Intervention / Treatment: Other: PAFA; Other: tumor ablation

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PAFA and tumor ablation; first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor	Other: PAFA; percutaneous ablation of tumor feeding artery; Other Names: percutaneous ablation of tumor feeding artery; Other: tumor ablation; ablation of tumor area directly
Other: tumor ablation; ablation of tumor directly	Other: tumor ablation; ablation of tumor area directly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
completed tumor necrosis	Contrast enhanced CT or MRI was examed to evaluate tumor necrosis 1 month after ablation.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tumor recurrence	tumor recurrence around the ablation zone	up to 36 months

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Study Director: Kun Yan, master, Peking University Cancer Hospital & Institute

Publications and helpful links

General Publications

• Zhang ZY, Lee JC, Yang W, Yan K, Wu W, Wang YJ, Chen MH. Percutaneous ablation of the tumor feeding artery for hypervascular hepatocellular carcinoma before tumor ablation. Int J Hyperthermia. 2018;35(1):133-139. doi: 10.1080/02656736.2018.1484525. Epub 2018 Jul 12. Erratum In: Int J Hyperthermia. 2018;35(1):140.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2014
• Primary Completion (Actual): March 31, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Ablation Techniques
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: Z151100004015186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No