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

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ClinicalTrials.gov Identifier: NCT03143140
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Kun Yan, Beijing Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Liver Neoplasms Other: PAFA Other: tumor ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Clinical Value of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma
Actual Study Start Date : May 22, 2014
Actual Primary Completion Date : March 31, 2018
Estimated Study Completion Date : December 1, 2018

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 Name: percutaneous ablation of tumor feeding artery

Other: tumor ablation
ablation of tumor area directly

tumor ablation
ablation of tumor directly
Other: tumor ablation
ablation of tumor area directly




Primary Outcome Measures :
  1. completed tumor necrosis [ Time Frame: 1 month ]
    Contrast enhanced CT or MRI was examed to evaluate tumor necrosis 1 month after ablation.


Secondary Outcome Measures :
  1. tumor recurrence [ Time Frame: up to 36 months ]
    tumor recurrence around the ablation zone



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143140


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Study Director: Kun Yan, master Beijing Cancer Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kun Yan, Director of ultrasonography department, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03143140     History of Changes
Other Study ID Numbers: Z151100004015186
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kun Yan, Beijing Cancer Hospital:
Ablation Techniques

Additional relevant MeSH terms:
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Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Digestive System Diseases
Liver Diseases