NCT03143140

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

3.9 years

First QC Date

May 4, 2017

Last Update Submit

October 16, 2018

Conditions

Keywords

Ablation Techniques

Outcome Measures

Primary Outcomes (1)

  • completed tumor necrosis

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

    1 month

Secondary Outcomes (1)

  • tumor recurrence

    up to 36 months

Study Arms (2)

PAFA and tumor ablation

EXPERIMENTAL

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

Other: PAFAOther: tumor ablation

tumor ablation

OTHER

ablation of tumor directly

Other: tumor ablation

Interventions

PAFAOTHER

percutaneous ablation of tumor feeding artery

Also known as: percutaneous ablation of tumor feeding artery
PAFA and tumor ablation

ablation of tumor area directly

PAFA and tumor ablationtumor ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Kun Yan, master

    Peking University Cancer Hospital & Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of ultrasonography department

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

May 22, 2014

Primary Completion

March 31, 2018

Study Completion

December 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations