Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis

Study Overview
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Brief Summary
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Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.

Official Title
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The Influence of Radiofrequency-assisted Hepatectomy on the Perioperative Outcomes and the Long-term Prognosis of HCC With Cirrhosis：A Prospective Randomized Controlled Trial

Conditions
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Hepatocellular Carcinoma, Cirrhosis

Intervention / Treatment
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* Procedure: Radiofrequency-assisted Hepatectomy
* Procedure: Conventional Hepatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 to 65 years , no gender restriction. Clinical diagnosis of resectable HCC. Preoperative liver function test showed Child-Pugh Class A or B. Indocyanine green retention at 15 minutes (ICG-15) of <30%. Acceptable clotting profile :platelet count > 50 x 109/L and a prolonged prothrombin time of < 5 seconds. Enough relative residual liver volume (%RLV) ≥ 40%. No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava. No other anti-tumor therapy received before the treatment. No metastasis in lymphnode or other organs. Written consent inform assigned. Exclusion Criteria: Pregnancy. Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis. Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiofrequency-assisted resection group（RF-R)<br>Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection. | Procedure: Radiofrequency-assisted Hepatectomy<br>* Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.<br>|
| Active Comparator: conventional liver resection group（CLR-R）<br>Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical. | Procedure: Conventional Hepatectomy<br>* Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative liver injury | The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days. | postoperative 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured. | postoperative 90 days | 
| Overall survival |  | 1,3,5-year overall survival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency-assisted（RF）, hepatectomy, postoperative liver injury