Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma

May 29, 2022 updated by: ChenJian

A Randomized Controlled Trial of Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma

The purpose of this research is to compare short-term and long-term efficacy of laparoscopic hepatectomy and radiofrequency ablation in the Treatment of early hepatocellular carcinoma, and provide the evidence for the choice of surgical method from the pathology and cytology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:The aim of this study was to compare the efficacy of laparoscopic hepatectomy(LH) with radiofrequency ablation (RFA) in the treatment of early hepatocellular carcinoma (HCC).

Methods:A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period.

Results:

operation time, intraoperative blood loss, rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, number of micrometastases ,long-term curative effect and survival time were collected and analysed.

groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank survival curves were used.

Study Type

Interventional

Enrollment (Actual)

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
        • JianChen

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:

  • Any gender,18 to 70 years old;
  • Preoperative diagnosis of primary liver clear;
  • No active hepatitis and decompensated cirrhosis;
  • Maximum diameter ≤3cm single nodules or three nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn;
  • No tumor rupture or bleeding;
  • Child-Pugh class A or B grade,ICG-R15 <14%;
  • No coagulation disorders,platelet count > 50 × 109 / L and prolonged prothrombin time < 5 seconds;
  • Not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery;
  • Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications;
  • Voluntarily participate in the study,informed consent.

Exclusion Criteria:

  • Age < 18 years or > 70,pregnant and lactating women;
  • Primary liver cancer diagnosis is not clear
  • Liver function assessment:Child-PughC level,liver function reserve situation :ICGR-15> 14%
  • Tumor rupture has occurred,or has the line before surgery,radiofrequency ablation (RFA),TACE or chemotherapy cancer treatment;
  • Tips liver imaging with multiple ( > 3 ) lesion,or tumor diameter> 3 cm, clear portal vein,hepatic vein,inferior vena cava tumor thrombus trunk;
  • Preoperative liver metastasis;
  • Preoperative evaluation of cardiopulmonary dysfunction patients who can not tolerate surgery;
  • Intraoperative exploration has occurred disseminated tumor and / or lymph node metastasis;
  • Exploratory surgery found that non-hepatic primary tumors,such as colorectal metastases,hilar cell carcinoma;
  • Severe upper abdominal adhesions;
  • Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin;
  • Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic Hepatectomy
Procedure: Laparoscopic Hepatectomy
A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period
Active Comparator: Radiofrequency Ablation
Procedure: Radiofrequency Ablation
A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 5 years
follow-up after the surgery every 2 months, to understand relapse, death, statistics 1 year, 2-year and 3-year survival, disease-free survival, recurrence rate.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: Duration hospitalization(an expected average of 7 days)
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Duration hospitalization(an expected average of 7 days)

Collaborators and Investigators

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

Sponsor

ChenJian

Investigators

  • Study Chair: Jian Chen, Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2014

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 29, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chenjian-01

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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