Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)

NCT02675881 | Completed DMC

• 1 other identifier: SNUH-2013-1441
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA). A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study. Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.

Conditions

HCC; Metastasis

Keywords

RFA

Outcome Measures

Primary Outcomes (1)

• local tumor progression (LTP)

  12 months

Secondary Outcomes (3)

• Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)

  1 months

• rate of intrahepatic distant recurrence (IDR) after RFA

  12 months

• rate of extrahepatic metastasis (EM) after RFA

  12 months

Other Outcomes (6)

• Number of complication of RFA

  6 months

• Maximal diameter of ablative zone

  7 day

• ablation time

  1 day

Study Arms (2)

RFA DSM

ACTIVE COMPARATOR

Eligible patients who undergo RFA using DSM and separable clustered electrodes.

Device: DSM; Device: separable clustered electrode

RFA SSM

NO INTERVENTION

Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.

Interventions

DSM DEVICE

Monopolar RFA using dual switching mode (DSM)

RFA DSM

separable clustered electrode DEVICE

A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.

Also known as: Octopus(R)

RFA DSM

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
• histologically confirmed HCC
• histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
• equal to or larger than 2cm, equal to or smaller than 5cm
• available cross-sectional liver imaging within 30 days before RFA
• signed informed consent

You may not qualify if:

• history of local treatment on the index tumor
• more than three tumors in a patient
• tumors in central portion of portal vein or hepatic vein
• Child-Pugh class C
• vascular invasion by tumors
• uncorrected coagulopathy
• presence of multiple extrahepatic metastases

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 5, 2016
• Study Start: August 5, 2013
• Primary Completion: April 8, 2015
• Study Completion: July 13, 2015
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)