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

Seoul National University

Status: Completed

Conditions: Liver Fibroses; Liver Mass

Treatments: Device: CT/US fusion; Device: ultrasound shear wave elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT02967198

1508-099-695

Details and patient eligibility

About

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).

Full 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).

Enrollment: 185 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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185 participants in 1 patient group

CT/US fusion

Experimental group

Description:

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.

Treatment:

Device: ultrasound shear wave elastography

Device: CT/US fusion