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

Southwest Hospital, China100 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Hepatocellular Carcinoma Stage I Radiofrequency Ablation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, China

ENROLLING_BY_INVITATION

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: two-years local tumor progression-free survival

Secondary Outcomes

Tumor-free survival

The tumor did not recur after treatment.

Time frame: two-years tumor-free survival

Central Contacts

Kai Feng, M.D

CONTACT

+86-23-13228683383 fengkai7688@hotmail.com

Data from ClinicalTrials.gov

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