NCT02539212

Brief Summary

According to randomized controlled trial requirement, the therapeutic effectiveness of cooled-probe microwave ablation and radiofrequency ablation on early-stage hepatocellular carcinoma is compared to find a better approach for minimally invasive thermal ablation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2008

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

6.7 years

First QC Date

August 12, 2015

Last Update Submit

August 31, 2015

Conditions

Keywords

microwaveradiofrequencyablation

Outcome Measures

Primary Outcomes (1)

  • Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.

    up to 79 months

Secondary Outcomes (4)

  • disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.

    up to 79 months

  • Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and RFA was done by the log-rank test.

    up to 79 months

  • An independent Student's t-test was used for comparing treatment parameters(power, time, session,etc)between MWA and RFA.

    up to 79 months

  • Wilcoxon test was used for comparing liver function between MWA and RFA.

    up to 79 months

Study Arms (2)

microwave ablation

ACTIVE COMPARATOR

microwave ablation

Device: microwave ablation

radiofrequency ablation

ACTIVE COMPARATOR

radiofrequency ablation

Device: radiofrequency ablation

Interventions

ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

microwave ablation

ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients

radiofrequency ablation

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tumor size ≤5cm in diameter,
  • tumor number ≤3,
  • Child-Pugh class A or B classification,
  • no evidence of extrahepatic metastasis,
  • vein or bile duct tumor embolus, and
  • no any other anti-cancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Ping Liang, Doctor

    Chinese PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair

Study Record Dates

First Submitted

August 12, 2015

First Posted

September 2, 2015

Study Start

October 1, 2008

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations