Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular Carcinoma
NCT ID: NCT02243384
Last Updated: 2022-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2014-09-01
2021-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Laparoscopic Hepatectomy
Laparoscopic Hepatectomy
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
Radiofrequency Ablation
Radiofrequency Ablation
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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ChenJian
OTHER
Responsible Party
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ChenJian
Associate Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
Principal Investigators
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Jian Chen
Role: STUDY_CHAIR
Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Locations
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JianChen
Chongqing, Chongqing Municipality, China
Countries
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References
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Feng K, Yan J, Li X, Xia F, Ma K, Wang S, Bie P, Dong J. A randomized controlled trial of radiofrequency ablation and surgical resection in the treatment of small hepatocellular carcinoma. J Hepatol. 2012 Oct;57(4):794-802. doi: 10.1016/j.jhep.2012.05.007. Epub 2012 May 23.
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Song J, Cao L, Ma K, Li J, Wang X, Chen J, Zheng S. Laparoscopic liver resection versus radiofrequency ablation for small hepatocellular carcinoma: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae099. doi: 10.1093/bjs/znae099.
Other Identifiers
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chenjian-01
Identifier Type: -
Identifier Source: org_study_id
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