Clinical trial NCT02243384: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Early Hepatocellular Carcinoma
Laparoscopic Hepatectomy
Radiofrequency Ablation
Micrometastases
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Survival rate
timeFrame: 5 years
Secondary outcomes:
measure: postoperative complications
timeFrame: Duration hospitalization(an expected average of 7 days)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: JianChen
state: Chongqing
Study officials:
affiliation: Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Jian Chen
role: STUDY_CHAIR
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