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FREE-hand versus NAVIgation guided percutaneous liver tumor ablation

FREE-hand versus NAVIgation guided percutaneous liver tumor ablation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21488
Enrollment
42
Registered
2016-09-14
Start date
2017-02-07
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma Colorectal Liver Metastasis Hepatocellulair carcinoom Colorectale lever metastase

Interventions

CT-guided percutaneous liver tumor ablation

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Indication to be treated by CT-guided percutaneous liver ablation • Age >18 years • Able to read Dutch language • Signed written informed consent • Physical and mental state allow general anesthesia as judged by the anesthesiologist

Exclusion criteria

Exclusion criteria: Every patient who qualifies for a percutaneous ablation of a liver tumour, can participate in the study except for patients in whom intravenous contrast cannot be administered. This can happen in patients in whom no contrast can be given despite preventive measures like untreatable contrast allergy or severe kidney dysfunction in whom even pre-hydration and other measures according to the UMCG contrast-nephropathy protocol do not allow i.v. contrast injection. Since precision is an important issue in this study, liver tumors need to be precisely located and measured. Therefore precise demarcation of the tumor in relation to the surrounding liver parenchyma is essential and this requires the use of i.v. contrast. Rarely, tumors are visible on non-contrast-enhanced CT scans. Patients with absolute contraindications for contrast administration will nevertheless be treated by percutaneous ablation, but we do not want to include these patients in this study.

Design outcomes

Primary

MeasureTime frame
The number of needle insertions to reach an adequate target position.

Secondary

MeasureTime frame
-1- deviation from predefined optimal tip-of-needle position based on lateral displacement (3D), angle deviation and longitudinal displacement, -2- time span needed to obtain adequate position, -3- number of control CT scans during the procedure to check the needle position, including calculation of radiation dose, -4- completeness of ablation zone as evaluated during the standard one-week post-procedural CT scan.

Contacts

Public ContactW.J. Heerink

HPC: EB45

Email: w.j.heerink@umcg.nlTel: +31503611144

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)