Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT02967198
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).
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: S-shear wave
Time frame: 10 minutes after finishing planning USG
comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG
Time frame: 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).
Time frame: 10 minutes after finishing planning USG
comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG
Time frame: 10 minutes after finishing planning USG
comparison of number of patients with presence/absence of safety access route, and the on two planning USGs
Seoul National University Hospital
Other
Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04785937
Digestive System Diseases, Fatty Liver
Reggio Emilia, RE, Italy
View Trial DetailsNCT04682600
Digestive System Diseases, Fatty Liver
Boston, Massachusetts, United States
View Trial DetailsNCT03149627
Alcohol-Induced Disorders, Alcohol-Related Disorders
Lusaka, Zambia
View Trial DetailsNCT03483584
Avitaminosis, Bone Diseases
Shatin, Hong Kong
View Trial Details