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

NCT ID: NCT02967198

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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

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Liver Mass Liver Fibroses

Keywords

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Fusion Ablation Percutaneous biopsy Shear wave elastography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CT/US fusion

Intervention Type DEVICE

Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.

ultrasound shear wave elastography

Intervention Type DEVICE

ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.

Interventions

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CT/US fusion

Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.

Intervention Type DEVICE

ultrasound shear wave elastography

ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.

Intervention Type DEVICE

Other Intervention Names

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S-shear wave

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1508-099-695

Identifier Type: -

Identifier Source: org_study_id