Radiofrequency Ablation Using Cooled-Wet Electrode

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02675894
• Collaborator: RF medical (Other), Medical Research Collaborating Center (Other)
• Enrollment: 77
• Location: 1
• Arms: 2
• Actual Duration (Months): 48.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.

Condition or Disease	Intervention/Treatment	Phase
HCC; Metastasis	Device: cooled-wet electrode; Device: separable clustered electrode	N/A

Detailed Description

To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
• Actual Study Start Date: Apr 14, 2014
• Actual Primary Completion Date: Jan 19, 2017
• Actual Study Completion Date: Apr 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RFA with cooled-wet electrode RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.	Device: cooled-wet electrode; RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.
Active Comparator: RFA with separable clustered electrode RFA using separable clustered electrode in switching monopolar mode under the fused US guidance	Device: separable clustered electrode; RFA is performed using separable clustered electrode in switching monopolar mode.; Other Names: Octopus(R)

Outcome Measures

Primary Outcome Measures

1. LTP [24 months]

   cumulating local tumor progression rate over 2- year after RFA

Secondary Outcome Measures

1. Technical success rate [1 months]

   technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)

2. IDR rate [24 months]

   cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA

3. EM rate [24 months]

   cumulating extrahepatic metastasis (EM) rate over 2- year after RFA

4. Maximal diameter of ablative zone [7 day]

   Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.

5. ablation time [1 day]

   RFA procedure time in each patient.

6. Complication [12 months]

   all complication rate and grades (according to Clavien system from I to III) related with RFA procedure

7. Volume of ablative zone [7 days]

   Volume of ablative zone on post-RFA CT or MRI in a mm3.

Other Outcome Measures

1. US/CT or MR fusion success rate [1 day]

   RFA is performed under real time US guidance and US is fused with pre-RFA CT or MRI before ablation of the index tumor. US/CT or US/MR fusion quality is assessed by an operator.

2. Immediate assess of technique success rate [2 days]

   After performing RFA, patients were transferred CT unit to confirm immediate technique success. It is performed in both a) visual inspection using pre-and post-RFA images side-by-side comparison and b) software assisted inspection which register pre-and post-RFA scans. The results would be used to perform additional treatment (2nd look RFA).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: all conditions have to be fulfilled.

• Diagnosed with HCC (1~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA

• liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging

• signed informed consent

• treatment naive index tumor (no history of local treatment for an index tumor)

Exclusion Criteria:

• more than three tumors in a patients

• tumor size larger than 5cm

• tumor attaches to central portal vein or hepatic vein

• Child-Pugh classification C

• uncorrected coagulopathy

• presence of extrahepatic metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital
• RF medical
• Medical Research Collaborating Center

Investigators

• Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02675894
• Other Study ID Numbers: SNUH-2013-2283
• First Posted: Feb 5, 2016
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital: RFA
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Mar 18, 2021