Back to resultsStandard Treatments of Very-early Stage Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Very-early Stage
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RFA
MWV
PEI
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring treatments, hepatocellular carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Eastern hepatobilliary surgery hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
RFA
MWV
PEI
Arm Description
Radiofrequency ablation
Microwave ablation
Percutaneous ethanol injection
Outcomes
Primary Outcome Measures
Recurrence
Hepatocellular Carcinoma will recurrence in 3 years
Death
Secondary Outcome Measures
Full Information
NCT ID
NCT02728193
First Posted
March 28, 2016
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02728193
Brief Title
Standard Treatments of Very-early Stage Hepatocellular Carcinoma
Official Title
The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Very-early Stage
Keywords
treatments, hepatocellular carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA
Arm Type
Experimental
Arm Description
Radiofrequency ablation
Arm Title
MWV
Arm Type
Experimental
Arm Description
Microwave ablation
Arm Title
PEI
Arm Type
Experimental
Arm Description
Percutaneous ethanol injection
Intervention Type
Procedure
Intervention Name(s)
RFA
Intervention Type
Procedure
Intervention Name(s)
MWV
Other Intervention Name(s)
Microwave ablation
Intervention Type
Procedure
Intervention Name(s)
PEI
Intervention Description
Percutaneous ethanol injection
Primary Outcome Measure Information:
Title
Recurrence
Description
Hepatocellular Carcinoma will recurrence in 3 years
Time Frame
3 years
Title
Death
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
12. IPD Sharing Statement
Learn more about this trial
Standard Treatments of Very-early Stage Hepatocellular Carcinoma
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