Pre-procedure Planning for Radiofrequency Ablation Using CT or MR/US Fusion

Not Applicable

Completed

• Conditions: Liver Cancer

• Registration Number: NCT02687113
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance alone.

Detailed Description

RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors in comparison with conventional US alone technique.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-19
• Last Update Submitted: 2016-02-19
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

all conditions should be satisfied for inclusion.

• referred to Radiology in our institution for liver tumor RFA
• available pre-RFA liver CT or liver MR imaging within 6 weeks

Exclusion Criteria

patients with any of following condition should be excluded.

• any contraindication of liver RFA
• any patients who received treatment between pre-RFA imaging and planned RFA
• patients referred for palliative purpose.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
RFA feasibility rates on planning USG with/without fusion CT/MR and US	10 minutes after finishing planning USG	comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG

Secondary Outcome Measures

Name	Time	Method
Number of patients with safety access route on planning USG with/without fusion technique	10 minutes after finishing planning USG	comparison of number of patients with presence/absence of safety access route, and the on two planning USGs
Rate of tumor visibility on planning USG with/without fusion technique	10 minutes after finishing planning USG	comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of