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CompletedNCT02728193Updated Apr 5, 2016

Standard Treatments of Very-early Stage Hepatocellular Carcinoma

An interventional study of RFA and MWV in Hepatocellular Carcinoma and Very-early Stage, sponsored by Eastern Hepatobiliary Surgery Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-05.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Very-early Stage

Keywords

  • treatments
  • hepatocellular carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 300 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 66 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    RFA

    Radiofrequency ablation

    Procedure: RFA

  • Experimental
    MWV

    Microwave ablation

    Procedure: MWV

  • Experimental
    PEI

    Percutaneous ethanol injection

    Procedure: PEI

Interventions

  • ProcedureRFA
  • ProcedureMWV

    Also known as: Microwave ablation

  • ProcedurePEI

    Percutaneous ethanol injection

06

What researchers measure

Primary outcomes

  1. Recurrence

    Hepatocellular Carcinoma will recurrence in 3 years

    Time frame: 3 years

  2. Death

    Time frame: 3 years

07

Study locations

1 site
  • Eastern hepatobilliary surgery hospital
    Shanghai, Shanghai 200438, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02728193
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Responsible party
ShenFeng (vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
Apr 5, 2016
Start date
Dec 2012
Primary completion
Dec 2014
Completion
Dec 2015
Last update
Apr 5, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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