The Short-term Efficacy of Novel NTDP-RFA in the Treatment of Small HCC With Cirrhosis.

Study Overview
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Brief Summary
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To evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.

Detailed Description
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Liver cancer is the fourth leading cause of cancer-related deaths globally. Hepatocellular carcinoma (HCC) accounts for 70% to 85% of primary HCC and is the leading cause of death in patients with cirrhosis. We developed a novel no-touch combined directional perfusion radiofrequency ablation system.By inserting two or more electrodes around the tumor and activating them simultaneously.The hypertonic saline solution can be directed into the focal tissue from a lateral pore through a tube within the electrode to provide more uniform and thorough necrosis.The maximum ablation volume was increased while the loss of normal tissue in the non-injection direction was reduced, thus reducing the incidence of postoperative complications. Therefore, the purpose of this study was to evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.

Official Title
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The Short-term Efficacy of Novel No-touch Combined Directional Perfusion Radiofrequency Ablation in the Treatment of Small Hepatocellular Carcinoma With Cirrhosis.

Conditions
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Hepatocellular Carcinoma Stage I, Radiofrequency Ablation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hepatocellular carcinoma with a background of cirrhosis Single shot with diameter ≤ 3cm The tumor did not invade portal vein, hepatic vein trunk and secondary branches Child Pugh A/B ICG-R15 ≤ 30% 18-70 years old The follow-up time reached 2 years Exclusion Criteria: The follow-up time is less than 2 years multiple lesions or diameter > 3cm Previous history of upper gastrointestinal bleeding or severe hypersplenism Patients with extrahepatic or lymph node metastasis Wish to receive liver transplantation and hepatectomy The lesion is adjacent to the gallbladder, important blood vessels and bile ducts in the hilum of the liver and important organs around severe bleeding tendency, platelet count < 50 × 10^9/L, or prothrombin time prolonged > 3s Other anti-tumor therapies were accepted before surgery

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

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of local tumor progression (LTP) | LTP was defined as the appearance of new tumor foci near 2 cm at the ablative margin after the local eradication of all tumor cells with RFA | two-years local tumor progression-free survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor-free survival | The tumor did not recur after treatment. | two-years tumor-free survival |