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

Radiofrequency Ablation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513119
• Other study ID #: cstc2019jscx-msxmX0230
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2020
• Source: Southwest Hospital, China
• Contact: Kai Feng, M.D
• Phone: +86-23-13228683383
• Email: fengkai7688[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Stage I
• Radiofrequency Ablation

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,Southwest Hospital	Chongqing	Chongqing
China	Institute of hepatobiliary surgery,Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tumor-free survival	The tumor did not recur after treatment.	two-years tumor-free survival