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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04513119
Enrollment
100
Registered
2020-08-14
Start date
2017-01-01
Completion date
2022-08-31
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma Stage I, Radiofrequency Ablation

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.

Interventions

None listed

Sponsors

Southwest Hospital, China
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of local tumor progression (LTP)two-years local tumor progression-free survivalLTP 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

MeasureTime frameDescription
Tumor-free survivaltwo-years tumor-free survivalThe tumor did not recur after treatment.

Countries

China

Contacts

Primary ContactKai Feng, M.D
fengkai7688@hotmail.com+86-23-13228683383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026