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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02967198
Other study ID # 1508-099-695
Secondary ID
Status Completed
Phase N/A
First received November 16, 2016
Last updated November 16, 2016
Start date November 2015
Est. completion date November 2016

Study information

Verified date November 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Completed
Enrollment 185
Est. completion date November 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
CT/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
ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary RFA or biopsy feasibility rates on planning USG with/without fusion CT/MR and US comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG 10 minutes after finishing planning USG No
Primary Assessment of a new point shear-wave elastography method (pSWE, S-shear wave) 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). 10 minutes after finishing planning USG No
Secondary Rate of tumor visibility on planning USG with/without fusion technique comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG 10 minutes after finishing planning USG No
Secondary Number of patients with safety access route on planning USG with/without fusion technique comparison of number of patients with presence/absence of safety access route, and the on two planning USGs 10 minutes after finishing planning USG No
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