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

Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans

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).

Study Overview

• Status: Completed
• Conditions: Liver Fibroses; Liver Mass
• Intervention / Treatment: Device: CT/US fusion; Device: ultrasound shear wave elastography

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).

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CT/US fusion; Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.; Device: ultrasound shear wave elastography; ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.; Other Names: S-shear wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Ablation; Fusion; Shear wave elastography; Percutaneous biopsy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 1508-099-695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO