Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Laparoscopic Hepatectomy 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 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
|
Outcome Measures
Primary Outcome Measures
- Survival rate [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.
Secondary Outcome Measures
- postoperative complications [Duration hospitalization(an expected average of 7 days)]
hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | JianChen | Chongqing | Chongqing | China | 400038 |
Sponsors and Collaborators
- ChenJian
Investigators
- Study Chair: Jian Chen, Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- chenjian-01