Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial

R C Rouchy, A Moreau-Gaudry, E Chipon, S Aubry, L Pazart, B Lapuyade, M Durand, M Hajjam, S Pottier, B Renard, R Logier, X Orry, A Cherifi, E Quehen, G Kervio, O Favelle, F Patat, E De Kerviler, C Hughes, M Medici, J Ghelfi, A Mounier, I Bricault, R C Rouchy, A Moreau-Gaudry, E Chipon, S Aubry, L Pazart, B Lapuyade, M Durand, M Hajjam, S Pottier, B Renard, R Logier, X Orry, A Cherifi, E Quehen, G Kervio, O Favelle, F Patat, E De Kerviler, C Hughes, M Medici, J Ghelfi, A Mounier, I Bricault

Abstract

Background: Interventional radiology includes a range of minimally invasive image-guided diagnostic and therapeutic procedures that have become routine clinical practice. Each procedure involves a percutaneous needle insertion, often guided using computed tomography (CT) because of its availability and usability. However, procedures remain complicated, in particular when an obstacle must be avoided, meaning that an oblique trajectory is required. Navigation systems track the operator's instruments, meaning the position and progression of the instruments are visualised in real time on the patient's images. A novel electromagnetic navigation system for CT-guided interventional procedures (IMACTIS-CT®) has been developed, and a previous clinical trial demonstrated improved needle placement accuracy in navigation-assisted procedures. In the present trial, we are evaluating the clinical benefit of the navigation system during the needle insertion step of CT-guided procedures in the thoraco-abdominal region.

Methods/design: This study is designed as an open, multicentre, prospective, randomised, controlled interventional clinical trial and is structured as a standard two-arm, parallel-design, individually randomised trial. A maximum of 500 patients will be enrolled. In the experimental arm (navigation system), the procedures are carried out using navigation assistance, and in the active comparator arm (CT), the procedures are carried out with conventional CT guidance. The randomisation is stratified by centre and by the expected difficulty of the procedure. The primary outcome of the trial is a combined criterion to assess the safety (number of serious adverse events), efficacy (number of targets reached) and performance (number of control scans acquired) of navigation-assisted, CT-guided procedures as evaluated by a blinded radiologist and confirmed by an expert committee in case of discordance. The secondary outcomes are (1) the duration of the procedure, (2) the satisfaction of the operator and (3) the irradiation dose delivered, with (4) subgroup analysis according to the expected difficulty of the procedure, as well as an evaluation of (5) the usability of the device.

Discussion: This trial addresses the lack of published high-level evidence studies in which navigation-assisted CT-guided interventional procedures are evaluated. This trial is important because it addresses the problems associated with conventional CT guidance and is particularly relevant because the number of interventional radiology procedures carried out in routine clinical practice is increasing.

Trial registration: ClinicalTrials.gov identifier: NCT01896219 . Registered on 5 July 2013.

Keywords: Computed tomography; Computer-assisted medical intervention; Electromagnetic navigation; IMACTIS-CT®; Imaging guidance; Interventional radiology; Medical device; Minimally invasive.

Conflict of interest statement

Ethics approval and consent to participate

This trial is registered in the ClinicalTrials.gov database (NCT01896219) and was approved by the French Health Authority (Agence Nationale de Sécurité des Médicaments et des Produits de Santé, registered 19 June 2013 under ANSM reference number 2013-A00539-36) and the relevant ethics committee (Comité de Protection des Personnes, Sud-Est V, France, 12 June 2013, CPP reference number 13-CHUG-22). Both central ethics committees have approved this study for all eight centres involved. All patients signed a consent certificate before being enrolled in the trial, in accordance with the Declaration of Helsinki II.

Consent for publication

Not applicable.

Competing interests

IB is a member of the medical advisory board of IMACTIS® and participated in the design of the IMACTIS-CT® navigation system. The other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Screenshot of a computed tomography-guided percutaneous biopsy of a spinal lesion. The biopsy has been carried out using navigation assistance provided by the IMACTIS-CT® system. It can be seen that the estimated position of the trocar (blue) is accurate with respect to the real position of the trocar (white)
Fig. 2
Fig. 2
Clinical trial overview. CT Computed tomography, CT group Active comparator arm in which procedures are carried out guided by conventional computed tomography, NAV group Experimental arm of the trial in which procedures are carried out using navigation assistance
Fig. 3
Fig. 3
Participant timeline

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