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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT/US fusion | Other | patients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT/US fusion | Device | Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RFA feasibility rates on planning USG with/without fusion CT/MR and US | comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG | 10 minutes after finishing planning USG |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of tumor visibility on planning USG with/without fusion technique | comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG | 10 minutes after finishing planning USG |
| Number of patients with safety access route on planning USG with/without fusion technique |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated number of overlapping of RFA electrodes on planning USG with/without fusion technique | comparison of anticipated number of electrode overlapping on two planning USGs | 30 minutes after finishing planning USG |
Inclusion Criteria: all conditions should be satisfied for inclusion.
Exclusion Criteria: patients with any of following condition should be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27650284 | Derived | Ahn SJ, Lee JM, Lee DH, Lee SM, Yoon JH, Kim YJ, Lee JH, Yu SJ, Han JK. Real-time US-CT/MR fusion imaging for percutaneous radiofrequency ablation of hepatocellular carcinoma. J Hepatol. 2017 Feb;66(2):347-354. doi: 10.1016/j.jhep.2016.09.003. Epub 2016 Sep 17. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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comparison of number of patients with presence/absence of safety access route, and the on two planning USGs |
| 10 minutes after finishing planning USG |
| D008107 |
| Liver Diseases |