Back to resultsLaparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic Hepatectomy
Radiofrequency Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Early Hepatocellular Carcinoma, Laparoscopic Hepatectomy, Radiofrequency Ablation, Micrometastases
Eligibility Criteria
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.
Sites / Locations
- JianChen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic Hepatectomy
Radiofrequency Ablation
Arm Description
Laparoscopic Hepatectomy
Radiofrequency Ablation
Outcomes
Primary Outcome Measures
Survival rate
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.
Secondary Outcome Measures
postoperative complications
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02243384
Brief Title
Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
Official Title
A Randomized Controlled Trial of Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ChenJian
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Early Hepatocellular Carcinoma, Laparoscopic Hepatectomy, Radiofrequency Ablation, Micrometastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants and researchers do not understand the test grouping, but the research designer arranges and controls all trials.
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Hepatectomy
Arm Type
Experimental
Arm Description
Laparoscopic Hepatectomy
Arm Title
Radiofrequency Ablation
Arm Type
Active Comparator
Arm Description
Radiofrequency Ablation
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Hepatectomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Intervention Description
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
Primary Outcome Measure Information:
Title
Survival rate
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
postoperative complications
Description
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Time Frame
Duration hospitalization(an expected average of 7 days)
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Chen
Organizational Affiliation
Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
JianChen
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
12. IPD Sharing Statement
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Learn more about this trial
Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
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