Clinical trial NCT04513119: The Short-term Efficacy of Novel NTDP-RFA in the Treatment of Small HCC With Cirrhosis.
Official title: 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
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma Stage I
Radiofrequency Ablation
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary hepatocellular carcinoma with cirrhosis

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of local tumor progression (LTP)
timeFrame: two-years local tumor progression-free survival
Secondary outcomes:
measure: Tumor-free survival
timeFrame: two-years tumor-free survival
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
state: Chongqing
Study officials:
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
name: Kuansheng Ma, Ph.D
role: STUDY_DIRECTOR
References: