Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging
- Conditions
- Liver FibrosesLiver Mass
- Interventions
- Device: CT/US fusionDevice: ultrasound shear wave elastography
- Registration Number
- NCT02967198
- Lead Sponsor
- Seoul National University Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
-
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
- any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CT/US fusion CT/US fusion patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or 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. CT/US fusion ultrasound shear wave elastography patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of