NCT02967198

Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging

Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Liver Mass
• Liver Fibroses

Interventions

Type	Name	Description
DEVICE	CT/US fusion	Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
DEVICE	ultrasound shear wave elastography	ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-09-01
• Completion: 2016-11-01
• First posted: 2016-11-18
• Last updated: 2016-11-18

Locations

1 site across 1 country: South Korea