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Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer

Primary Purpose

Liver Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
US-guided RFA
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT(platelet count) ≥ 50*10e9/L and PT(prothrombin time) ≤ 20s.

Exclusion Criteria:

  • Patients with blood coagulation dysfunction, ChildPugh score≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.

Sites / Locations

  • The First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA(radiofrequency ablation)

Arm Description

The investigators used percutaneously US-guided RFA(radiofrequency ablation) for small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.

Outcomes

Primary Outcome Measures

Tumor size assessed by MRI
Tumor size was estimated by MRI.

Secondary Outcome Measures

Carcinoembryonic Antigen (CEA) level assessed by ELISA
CEA level was assessed by enzyme linked immunosorbent assay (ELISA).
Alpha Fetoprotein (AFP) level assessed by ELISA
AFP level was assessed by ELISA.

Full Information

First Posted
January 4, 2017
Last Updated
July 26, 2018
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03026452
Brief Title
Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and efficacy of ultrasonography (US) -guided radiofrequency ablation for liver tumors, the investigators used preoperative and postoperative US/CEUS(contrast-enhanced ultrasonography)/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA(radiofrequency ablation)
Arm Type
Experimental
Arm Description
The investigators used percutaneously US-guided RFA(radiofrequency ablation) for small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.
Intervention Type
Procedure
Intervention Name(s)
US-guided RFA
Intervention Description
The investigators used percutaneously US-guided radiofrequency ablation for patients with small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.
Primary Outcome Measure Information:
Title
Tumor size assessed by MRI
Description
Tumor size was estimated by MRI.
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Carcinoembryonic Antigen (CEA) level assessed by ELISA
Description
CEA level was assessed by enzyme linked immunosorbent assay (ELISA).
Time Frame
through study completion, an average of 2 year
Title
Alpha Fetoprotein (AFP) level assessed by ELISA
Description
AFP level was assessed by ELISA.
Time Frame
through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT(platelet count) ≥ 50*10e9/L and PT(prothrombin time) ≤ 20s. Exclusion Criteria: Patients with blood coagulation dysfunction, ChildPugh score≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian'an Jiang, Phd
Phone
+86 18857127666
Email
tiananjiang@126.com
First Name & Middle Initial & Last Name & Degree
Guo Tian, Master
Phone
+86 13600529967
Email
871035504@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27916360
Citation
Sasaki K, Margonis GA, Andreatos N, Kim Y, Wilson A, Gani F, Amini N, Pawlik TM. Combined resection and RFA in colorectal liver metastases: stratification of long-term outcomes. J Surg Res. 2016 Nov;206(1):182-189. doi: 10.1016/j.jss.2016.06.098. Epub 2016 Jul 4.
Results Reference
result
PubMed Identifier
27793949
Citation
Giorgio A, Merola MG, Montesarchio L, Merola F, Santoro B, Coppola C, Gatti P, Amendola F, DI Sarno A, Calvanese A, Matteucci P, Giorgio V. Sorafenib Combined with Radio-frequency Ablation Compared with Sorafenib Alone in Treatment of Hepatocellular Carcinoma Invading Portal Vein: A Western Randomized Controlled Trial. Anticancer Res. 2016 Nov;36(11):6179-6183. doi: 10.21873/anticanres.11211.
Results Reference
result
PubMed Identifier
27781199
Citation
Makino Y, Imai Y, Igura T, Kogita S, Sawai Y, Fukuda K, Iwamoto T, Okabe J, Takamura M, Fujita N, Hori M, Takehara T, Kudo M, Murakami T. Feasibility of Extracted-Overlay Fusion Imaging for Intraoperative Treatment Evaluation of Radiofrequency Ablation for Hepatocellular Carcinoma. Liver Cancer. 2016 Oct;5(4):269-279. doi: 10.1159/000449338. Epub 2016 Sep 14.
Results Reference
result
PubMed Identifier
27780345
Citation
Aissou S, Cartier V, Hamy A, Plumereau F, Aube C, Lermite E. Radiofrequency in the Management of Colorectal Liver Metastases: A 10-Year Experience at a Single Center. Surg Technol Int. 2016 Oct 26;29:99-105.
Results Reference
result
PubMed Identifier
27766709
Citation
Barat M, Fohlen A, Cassinotto C, Jannot AS, Dautry R, Pelage JP, Boudiaf M, Pocard M, Eveno C, Taouli B, Soyer P, Dohan A. One-month apparent diffusion coefficient correlates with response to radiofrequency ablation of hepatocellular carcinoma. J Magn Reson Imaging. 2017 Jun;45(6):1648-1658. doi: 10.1002/jmri.25521. Epub 2016 Oct 20.
Results Reference
result
PubMed Identifier
27010381
Citation
Seror O, N'Kontchou G, Nault JC, Rabahi Y, Nahon P, Ganne-Carrie N, Grando V, Zentar N, Beaugrand M, Trinchet JC, Diallo A, Sellier N. Hepatocellular Carcinoma within Milan Criteria: No-Touch Multibipolar Radiofrequency Ablation for Treatment-Long-term Results. Radiology. 2016 Aug;280(2):611-21. doi: 10.1148/radiol.2016150743. Epub 2016 Mar 24. Erratum In: Radiology. 2016 Sep;280(3):981.
Results Reference
result

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Effectivity and Safety of Ultrasound-guided Percutaneously Radiofrequency Ablation for Liver Cancer

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