Purpose
To assess the accuracy and usability of a navigation system dedicated to assist CT guided interventions.
Accuracy of needle placement is critital for the success of percutaneous guided interventions and to avoid adverse events but some cases prove to difficult :
Double obliquity required to achieve a safe trajectory.
Patient's movements during the procedure.
Different navigation systems have been developed so far to assist CT quided interventions usingmechanical localization,
laser,
optical or electromagnetic tracking with the following limitations :
They often lack the possibility to...
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...
Results
N=120 patients enrolled between June 2010 and January 2012.Nineteen different operators (11 seniors,
8 residents) participated in the study.
Interventions were both scheduled and emergency procedures,
and included drainages,
biopsies,
tumor ablations (radiofrequency,
microwave and cryotherapy),
sympathicolyses and infiltrations (baseline - Table 1,
Patient Flow - Fig.
5).
Main outcome results (ITT) :
CT-group
NAV-group
p-value
Analyzed population
n=60
n=60
Distance(mm)
8.9 [4.9; 15.1]
4.1 [2.7; 9.1]
<0.001
Angle(°)
7.9 [5.9; 13.2]
4.7 [2.4; 8.2]
<0.001
Operator satisfaction after intervention (PP) :
CT-group
NAV-group
p-value...
Conclusion
This prospective randomized controlled trial suggest that the tested navigation system improves the accuracy of CT-guided interventions,
and that the system is usable in a routine clinical setting for a large variety of operators and types of interventions.
We note that the preparation phase (From planning to 1st needle) was longer in the NAV group,
this could be explained by :
Utilisation of a prototype version
Many different skilled radiologists used the system,
some of the for the first time,
this also shows that the...
References
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Silverman SG,
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Gupta S.
New techniques in image-guided percutaneous biopsy.
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3.
Bale R,
Widmann G.
Navigated CT-guided interventions.
Minim Invasive Ther Allied Technol 2007;16(4):196–204.
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Meyer BC,
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Value...
Personal Information
This work was supported by University Hospital Grenoble Delegation to Clinical Research with French Research National Agency funding support.
PD,
AMG,
JF,
MM,
EC,
CS have no conflict of interest do declare
IB was involved in the development of the system,
he did not participate in image post-treatment or statistical analysis.
Wewould like to thank Pr.
G.Ferretti for his involvement and always pertinent advices and help,
Dr A.Jankowski,
Dr J-N.Ravey,
Dr C.Dubois and Dr M.Prieur-Blaysat for their participation.
We thank the french Society of Abdominal...