Clinical trial NCT02967198: Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging
Official title: Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Mass
Liver Fibroses
Keywords: Fusion
Ablation
Percutaneous biopsy
Shear wave elastography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 185
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: RFA or biopsy feasibility rates on planning USG with/without fusion CT/MR and US
timeFrame: 10 minutes after finishing planning USG
measure: Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)
timeFrame: 10 minutes after finishing planning USG
Secondary outcomes:
measure: Rate of tumor visibility on planning USG with/without fusion technique
timeFrame: 10 minutes after finishing planning USG
measure: Number of patients with safety access route on planning USG with/without fusion technique
timeFrame: 10 minutes after finishing planning USG
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: