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

• Conditions: Radiofrequency Ablation; Hepatocellular Carcinoma Stage I

• Registration Number: NCT04513119
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-07-31
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-14
• Last Update Posted: 2020-08-14
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of local tumor progression (LTP)	two-years local tumor progression-free survival	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

Secondary Outcome Measures

Name	Time	Method
Tumor-free survival	two-years tumor-free survival	The tumor did not recur after treatment.

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China