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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.
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 automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 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 automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| automatic CT/MRI-US fusion system guided radiofrequency ablation | Procedure | automatic CT/MRI-US fusion system guided radiofrequency ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate of the fusion process | Absolute technical success rate of the fusion process | Immediately after fusion process |
| Technical success rate of the overall RFA procedure | Absolute technical success rate of the overall RFA compared to literature | immediately after RFA procedure |
| Rate of complete ablation of the tumor after 1 month clinical follow up | Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature | 1 month after the RFA procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor progression rate | Local tumor progression rate after follow up compared to literature | During post procedural follow up to 5 years |
| Tumor visibility before and after the fusion process |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee | Professor | Study Chair |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
| 10 minutes after finishing planning USG |
| Technical feasibility before and after the fusion process | Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. | 10 minutes after finishing planning USG |
| Safety of the approach route before and after the fusion process | Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. | 10 minutes after finishing planning USG |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |