Liver Fibroses, Liver Mass
Conditions
Keywords
Fusion, Ablation, Percutaneous biopsy, Shear wave elastography
Brief summary
The purpose of this study is to determine whether fusion technique of preradiofrequency ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).
Detailed description
RFA is one of commonly used local therapies for primary or secondary liver tumors. And percutaneous liver biopsy is very important technique to confirm the diagnosis of focal hepatic lesion whether benign or malignancy. For successful and safe procedure, safe access route and lesion visibility are essential , and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG). However, these procedure 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 or liver biopsy feasibility in patients with liver tumors in comparison with conventional US alone technique. In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).
Interventions
DEVICECT/US fusion
Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.
Sponsors
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 No maximum
Healthy volunteers
No
Inclusion criteria
* all conditions should be satisfied for inclusion. * referred to Radiology in our institution for liver tumor RFA or percutaneous liver biopsy * available pre-procedure liver CT or liver MR imaging within 6 weeks
Exclusion criteria
* any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RFA or biopsy 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 |
| Assessment of a new point shear-wave elastography method (pSWE, S-shear wave) | 10 minutes after finishing planning USG | To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed