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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Stage I Radiofrequency Ablation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No