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

Army Medical University

Status: Unknown

Conditions: Hepatocellular Carcinoma Stage I; Radiofrequency Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT04513119

cstc2019jscx-msxmX0230

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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