NCT03026452

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.

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
400

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

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

January 1, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 27, 2018

Status Verified

December 1, 2016

Enrollment Period

5.9 years

First QC Date

January 4, 2017

Last Update Submit

July 26, 2018

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor size assessed by MRI

    Tumor size was estimated by MRI.

    through study completion, an average of 2 year

Secondary Outcomes (2)

  • Carcinoembryonic Antigen (CEA) level assessed by ELISA

    through study completion, an average of 2 year

  • Alpha Fetoprotein (AFP) level assessed by ELISA

    through study completion, an average of 2 year

Study Arms (1)

RFA(radiofrequency ablation)

EXPERIMENTAL

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.

Procedure: US-guided RFA

Interventions

US-guided RFAPROCEDURE

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.

RFA(radiofrequency ablation)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 27916360RESULT

  • 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.

    PMID: 27793949RESULT

  • 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.

    PMID: 27781199RESULT

  • 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.

    PMID: 27780345RESULT

  • 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.

    PMID: 27766709RESULT

  • 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.

    PMID: 27010381RESULT

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 20, 2017

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 27, 2018

Record last verified: 2016-12

Locations

CN(1)