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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03143140
• Other study ID #: Z151100004015186
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2014
• Est. completion date: December 1, 2018

Study information

• Verified date: October 2018
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Other:
• PAFA
percutaneous ablation of tumor feeding artery
• tumor ablation
ablation of tumor area directly

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completed tumor necrosis	Contrast enhanced CT or MRI was examed to evaluate tumor necrosis 1 month after ablation.	1 month
Secondary	tumor recurrence	tumor recurrence around the ablation zone	up to 36 months