search
Back to results

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

Primary Purpose

Liver Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PAFA
tumor ablation
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring Ablation Techniques

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PAFA and tumor ablation

tumor ablation

Arm Description

first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor

ablation of tumor directly

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

tumor recurrence
tumor recurrence around the ablation zone

Full Information

First Posted
May 4, 2017
Last Updated
October 16, 2018
Sponsor
Peking University Cancer Hospital & Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03143140
Brief Title
The Effect of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma
Official Title
The Clinical Value of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2014 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
Keywords
Ablation Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAFA and tumor ablation
Arm Type
Experimental
Arm Description
first percutaneous frequency ablation of tumor feeding artery and then ablation of tumor
Arm Title
tumor ablation
Arm Type
Other
Arm Description
ablation of tumor directly
Intervention Type
Other
Intervention Name(s)
PAFA
Other Intervention Name(s)
percutaneous ablation of tumor feeding artery
Intervention Description
percutaneous ablation of tumor feeding artery
Intervention Type
Other
Intervention Name(s)
tumor ablation
Intervention Description
ablation of tumor area directly
Primary Outcome Measure Information:
Title
completed tumor necrosis
Description
Contrast enhanced CT or MRI was examed to evaluate tumor necrosis 1 month after ablation.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
tumor recurrence
Description
tumor recurrence around the ablation zone
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: tumor number ≤3， maximum tumor size ≤5cm; accessibility of tumors via a percutaneous approach; tumor feeding artery can be detected by 3D contrast enhance ultrasound; platelet count ≥ 50,000/ml and INR <1.6; life expectancy more than 6 months Child grade A or B Exclusion Criteria: patients who scheduled liver transplantation with extrahepatic metastasis women during menstruation, pregnancy, child birth and baby nursing period patients with severe mental disorder cardiopulmonary failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Yan, master
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29999436
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs