Standard Treatments of Very-early Stage Hepatocellular Carcinoma

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA
Radiofrequency ablation
Procedure: RFA
Experimental: MWV
Microwave ablation
Procedure: MWV
Other Names:
  • Microwave ablation
Experimental: PEI
Percutaneous ethanol injection
Procedure: PEI
Percutaneous ethanol injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 3 years
3 years
Recurrence
Time Frame: 3 years
Hepatocellular Carcinoma will recurrence in 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012ZX10002016003001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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