NCT02728193

Brief Summary

The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
Last Updated

April 5, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 28, 2016

Last Update Submit

March 30, 2016

Conditions

Hepatocellular CarcinomaVery-early Stage

Keywords

treatmentshepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

  • Recurrence

    Hepatocellular Carcinoma will recurrence in 3 years

    3 years

  • Death

    3 years

Study Arms (3)

RFA

EXPERIMENTAL

Radiofrequency ablation

Procedure: RFA

MWV

EXPERIMENTAL

Microwave ablation

Procedure: MWV

PEI

EXPERIMENTAL

Percutaneous ethanol injection

Procedure: PEI

Interventions

RFAPROCEDURE
RFA
MWVPROCEDURE
Also known as: Microwave ablation
MWV
PEIPROCEDURE

Percutaneous ethanol injection

PEI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma
  • Tumor diameter\<2cm
  • Child-Pugh class A liver function
  • Without major organ dysfunction
  • male or female patients \> 18 years and \<=70 years of age
  • Voluntary participation in this clinical trial

You may not qualify if:

  • Other anticancer treatment before therapy
  • Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
  • Patients with other diseases that may affect the treatment of this treatment
  • History of other malignant tumors
  • Patients who are participating in other clinical trials
  • Pregnant, lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

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
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 5, 2016

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

April 5, 2016

Record last verified: 2016-03

Locations

CN(1)