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

NCT ID: NCT03143140

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-22

Study Completion Date

2018-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PAFA and tumor ablation

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

Group Type EXPERIMENTAL

PAFA

Intervention Type OTHER

percutaneous ablation of tumor feeding artery

tumor ablation

Intervention Type OTHER

ablation of tumor area directly

tumor ablation

ablation of tumor directly

Group Type OTHER

tumor ablation

Intervention Type OTHER

ablation of tumor area directly

Interventions

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PAFA

percutaneous ablation of tumor feeding artery

Intervention Type OTHER

tumor ablation

ablation of tumor area directly

Intervention Type OTHER

Other Intervention Names

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percutaneous ablation of tumor feeding artery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Kun Yan

Director of ultrasonography department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kun Yan, master

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29999436 (View on PubMed)

Other Identifiers

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Z151100004015186

Identifier Type: -

Identifier Source: org_study_id

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