Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation

Phase 2

Completed

• Conditions: HCC
• Interventions: Diagnostic Test: Additional intraprocedural pre-ablation CT-scan

• Registration Number: NCT04123340
• Lead Sponsor: Leiden University Medical Center

Brief Summary

A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-26
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Primary Completion: 2021-08-26
• Study Completion: 2021-08-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18 yrs or above
• HCC very early (0) or early stage (A) according to the BCLC staging system
• Either de novo or recurrent HCC (prior locoregional therapy is allowed in the study)
• Candidate for percutaneous thermal ablation as discussed in a multidisciplinary tumor board. Ablation as 'bridge-to-transplant' is allowed in the study

Exclusion Criteria

• Estimated GFR <30 ml/min
• Morbid obesitas or any pulmonary condition that is a contraindication to prolonged apnea and high jet-ventilation
• Child Pugh C
• Portal vein tumor invasion
• Extrahepatic metastasis
• Uncorrectable coagulopathy
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Inability or unwillingness to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional intraprocedural CT-scan	Additional intraprocedural pre-ablation CT-scan	Additional intraprocedural CT-scan

Primary Outcome Measures

Name	Time	Method
Feasibility of the use of co-registration software (>80%)	1 year	The proportion of patients in whom reliable co-registration of pre- and post-ablation CT images is feasible

Secondary Outcome Measures

Name	Time	Method
The time that is required for CT-CT co-registration	1 year	The time that is required for CT-CT co-registration
Inter and intra-observer variability	1 year	Inter- and intraobserver variability of CT-CT co-registration of determining the minimum ablation margin after thermal ablation for liver tumors
Quantitatively assessed ablation margin	1 year	Percentage of local recurrence per group as categorized according to ablation margin: \<0mm, 0-5mm, \>5mm

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands