Anatomical Radiofrequency Ablation for Small Hepatocellular Carcinoma

NCT05580224 | Unknown

• 1 other identifier: 2208-187-1355
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate therapeutic outcomes of anatomical radiofrequency ablation for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Technical success

  Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.

  Immediately after radiofrequency ablation

• Local tumor progression rate

  Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success.

  12 months after radiofrequency ablation

Secondary Outcomes (2)

• Complication after radiofrequency ablation

  Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation

• Recurrence-free survival

  12 months after radiofrequency ablation

Study Arms (1)

Patients with hepatocellular carcinoma (equal or less than 3 cm)

EXPERIMENTAL

Under the guidance of multimodality-ultrasound (US) fusion image, one of the three electrodes was placed across the portal vein branch near the tumor, and the other two electrodes were placed around the tumor through the previously planned approach path. After placement of electrodes, the temperature is maintained at 90-100 degrees Celsius for about 6-30 minutes depending on the size of the tumor, using the combined energy transfer mode that sequentially adds the bipolar mode and/or the monopolar mode.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Radiofrequency ablation is performed for peripherally located small hepatocellular carcinoma using combined energy delivery mode and triple cooled-wet electrodes. One of three electrodes is placed across the 4th or 5th portal vein branches near the target tumor which enables anatomical ablation of tumor.

Patients with hepatocellular carcinoma (equal or less than 3 cm)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Child-Pugh class A or B7.
• Presence of chronic hepatitis B or liver cirrhosis.
• Patients with hepatocellular carcinomas diagnosed by histopathology or noninvasive imaging-based diagnosis according to the Korean Liver Cancer Association-National Cancer Center Korea guidelines.
• Patients with viable hepatocellular carcinoma after locoregional treatment diagnosed by the Liver Imaging Reporting and Data System.
• Tumor location is less than 5 cm from liver capsule.

You may not qualify if:

• The number of tumor is three or more.
• Tumor size is over 3 cm.
• Tumor location is over 5 cm from liver capsule.
• Child-Pugh class B8-9 or C.
• Presence of macrovascular invasion and/or distant metastasis.
• Platelet count \< 50,000 mm3, or international normalized ratio \> 1.5 (prothrombin time \>1.5 × normal).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jeong Min Lee, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Hee Lee

CONTACT

82-2-2072-4177; redlion55@naver.com

Jae Hyun Kim, M.D.

CONTACT

82-2-2072-2519; yyssaa21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: October 4, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

KR (1)