Hepatocellular Carcinoma
Conditions
Keywords
Radiofrequency ablation, Fusion imaging
Brief summary
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.
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 automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.
Interventions
PROCEDUREautomatic CT/MRI-US fusion system guided radiofrequency ablation
automatic CT/MRI-US fusion system guided radiofrequency ablation
Sponsors
Philips Healthcare
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Pathologic or typical imaging based diagnosis of HCC * Multiphase CT or MRI within 3 months ahead of procedure * No evidence of distant metastasis * No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet \> 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number \>4, largest tumor size \> 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.
Exclusion criteria
* Lack of multiphase CT or MRI withing 3 months ahead of procedure * RFA planned for palliative purpose * Diagnosed as non-HCC malignancy * Right hepatectomy state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate of the fusion process | Immediately after fusion process | Absolute technical success rate of the fusion process |
| Technical success rate of the overall RFA procedure | immediately after RFA procedure | Absolute technical success rate of the overall RFA compared to literature |
| Rate of complete ablation of the tumor after 1 month clinical follow up | 1 month after the RFA procedure | Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local tumor progression rate | During post procedural follow up to 5 years | Local tumor progression rate after follow up compared to literature |
| Safety of the approach route before and after the fusion process | 10 minutes after finishing planning USG | Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. |
| Tumor visibility before and after the fusion process | 10 minutes after finishing planning USG | Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. |
| Technical feasibility before and after the fusion process | 10 minutes after finishing planning USG | Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process. |
Outcome results
None listed