Keywords:
Interventional non-vascular, Computer applications, CT, Percutaneous, Image manipulation / Reconstruction, Ablation procedures, Biopsy, Technology assessment
Authors:
P. Durand, A. Moreau-Gaudry, J. frandon, M. Medici, E. Chipon, C. SENGEL, I. BRICAULT; Grenoble/FR
DOI:
10.1594/ecr2013/B-0429
Methods and Materials
IRB approved,
open,
comparative,
prospective randomized controlled trial (ClinicalTrials.gov NCT00828893).
N=120 patients in two parallel groups 60 each were randomized to have standard procedure (CT group) or computer-assisted,
navigated procedure (NAV group) with the system described in the former section.
Inclusion criteria were :
- Indication of a percutaneous CT intervention without contraindications
- Adult patients,
ability to understand and sign informed consent
- Health insurance coverage.
Exclusion criteria were :
- Any stimulating device (pacemaker,
deep brain stimulator)
- Pregnant or breasting patient
- Unavailability of the navigation system or unavailability of a senior investigator.
After the first CT acquision,
the trajectory planning was computed on the CT scan console (CT group) or saved on the Navigation system (NAV group).
The main outcome was the accuracy of the needle initial placement,
defined as the maximal distance and angle between planned and realized trajectory.
Secondary outcomes were duration of interventions,
number of CT control acquisitions recessary to reach the target,
delivered X-ray dose and operator satisfaction.
To allow duration,
number of control CT acquisitions an delivered doses calculations,
interventions were split in 3 phases :
- From planning to first needle
- Progression to target
- (Intervention itself - not counted because not related to the utilisation of the navigation system)
Data were analyzed according to both the worse case scenario intention-to-treat (ITT) and the per protocol (PP) principles.