A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC

Study Overview
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Brief Summary
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To observe and compare the short-term and long-term oncological outcome of laparoscopic hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma .

Detailed Description
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Background & Aims: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death in the world. The 5-year recurrent rate of HCC after first curative resection is 77% 100%. Laparoscopic repeat liver resection (LRLR) has been shown in small retrospective studies to be a safe and effective treatment for recurrent hepatocellular carcinoma (rHCC) in selected patients, and radiofrequency ablation (RFA) has been increasingly performed for treating recurrent tumors involving the liver after hepatectomy. The aim of this study was to compare the short-term and long-term outcome of laparoscopic hepatectomy (LH) and radiofrequency ablation (RFA) in the treatment of rHCC.

Official Title
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A RCT Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC

Conditions
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Hepatocellular Carcinoma Recurrent

Intervention / Treatment
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* Procedure: Laparoscopic Hepatectomy
* Procedure: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any gender,18 to 70 years old; Preoperative diagnosis of recurrent HCC clear,liver resection was done previously; No active hepatitis and decompensated cirrhosis; Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 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 <20%; No coagulation disorders,platelet count > 50 × 109 / L and prolonged prothrombin time < 5 seconds; After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery; Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts; Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications; Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent. Exclusion Criteria: Opposite of the above inclusion criteria; 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; Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two different treatments are conducted on the participant base on the randomized choices
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Hepatectomy<br>Improvements in laparoscopic technology mean that LH now has superior short-term efficacy and similar long-term efficacy to open surgery , and LH has shown significant advantages in applications involving recurrent HCC. | Procedure: Laparoscopic Hepatectomy<br>* 180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.<br>|
| Active Comparator: Radiofrequency Ablation<br>With recent technological advances, RFA has become the most widely investigated new first-line therapeutic option for recurrent HCCs . Numerous large studies have demonstrated the advantages of RFA, which include its ease of use, safety, effectiveness, minimal invasiveness, and minimal morbidity and mortality . | Procedure: Radiofrequency Ablation<br>* 180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | follow-up after the surgery every 3 months, to understand statistics 5-year survival. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative parameters | operation time and hepatic inflow occlusion time will be combined to report intraoperative parameters in hour(h). | during the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent HCC, Laparoscopic Hepatectomy, RFA, RCT