Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

November 19, 2015 updated by: fengkai, Southwest Hospital, China

A Randomized Controlled Trial of Radiofrequency Ablation Assisted Hepatectomy and Hepatectomy Alone in the Treatment of Advanced Hepatocellular Carcinoma

RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced HCC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Institute of hepatobiliary surgery,southwest 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. Diagnosis of HCC confirmed at our hospital.
  2. Intrahepatic tumor count no higher than 3 and a minimum tumor diameter > 3 cm, but no more than 8cm.
  3. Liver function of Child-Pugh Class A or B.
  4. Tumors lacked intrahepatic and extrahepatic metastasis.
  5. Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
  6. Indocyanine green retention at 15 minutes (ICG-15) of <10%.
  7. No evidence of coagulopathy: platelet count > 50 × 109/L and a prolonged prothrombin time of < 5 seconds.
  8. No other anti-tumor therapy received before the treatment. -

Exclusion Criteria:

  1. Patients met the inclusion criteria but declined to participate.
  2. Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
  3. Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hepatectomy
Using Hepatectomy for the treatment of advanced HCC
Procedure: Hepatectomy
Treat the advanced HCC with the hepatectomy only.
EXPERIMENTAL: RFA assisted Hepatectomy
Ablating the liver tissue around the tumor before hepatectomy.
Procedure: RFA assisted Hepatectomy
Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free Survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Southwest Hospital, China

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

October 1, 2012

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

November 1, 2016

Study Registration Dates

First Submitted

October 21, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (ESTIMATE)

October 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKLKF201209

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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