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Trials. 2017 Jul 6;18(1):306. doi: 10.1186/s13063-017-2049-6.

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.

Rouchy RC1,2,3,4, Moreau-Gaudry A5,6,7,8, Chipon E9,5,10, Aubry S11,12, Pazart L12, Lapuyade B13, Durand M14,15,16, Hajjam M17, Pottier S18, Renard B19, Logier R20, Orry X21, Cherifi A22, Quehen E23, Kervio G24, Favelle O25, Patat F26, De Kerviler E27, Hughes C9,5,10, Medici M9,5,10, Ghelfi J28,9,5,10, Mounier A28,9,5,10, Bricault I28,5,6,7,8.

Author information

1
Clinique Universitaire de Radiologie et Imagerie Médicale, Centre Hospitalier Universitaire (CHU) de Grenoble-Alpes, F-38000, Grenoble, France. rcrouchy1@chu-grenoble.fr.
2
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1406, University Grenoble-Alpes, F-38000, Grenoble, France. rcrouchy1@chu-grenoble.fr.
3
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1406, F-38000, Grenoble, France. rcrouchy1@chu-grenoble.fr.
4
Pole Recherche, Centre Hospitalier Universitaire (CHU) de Grenoble-Alpes, F-38000, Grenoble, France. rcrouchy1@chu-grenoble.fr.
5
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1406, F-38000, Grenoble, France.
6
Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble (TIMC-IMAG), University Grenoble-Alpes, F-38000, Grenoble, France.
7
Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble (TIMC-IMAG), Centre national de la recherche scientifique (CNRS), F-38000, Grenoble, France.
8
Pole Sante Publique, Centre Hospitalier Universitaire (CHU) de Grenoble-Alpes, F-38000, Grenoble, France.
9
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1406, University Grenoble-Alpes, F-38000, Grenoble, France.
10
Pole Recherche, Centre Hospitalier Universitaire (CHU) de Grenoble-Alpes, F-38000, Grenoble, France.
11
Service de Radiologie Ostéo-Articulaire, Centre Hospitalier Universitaire (CHU) Besançon, F-25000, Besançon, France.
12
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1431, F-25000, Besançon, France.
13
Service d'Imagerie Diagnostique et Therapeutique, Centre Hospitalier Universitaire (CHU) Bordeaux, F-33000, Bordeaux, France.
14
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1401, F-33000, Bordeaux, France.
15
Centre d'Investigation Clinique (CIC) 1401, University Bordeaux, F-33000, Bordeaux, France.
16
Centre Hospitalier Universitaire (CHU) Bordeaux, F-33000, Bordeaux, France.
17
Service de Radiologie, Hôpital Ambroise-Paré, Assistance Publique-Hôpitaux de Paris (AP-HP), F-92100, Boulogne-Billancourt, France.
18
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1429, Hôpital Raymond-Poincaré, Assistance Publique-Hôpitaux de Paris (AP-HP), F-92380, Garches, France.
19
Service de Radiologie, Centre Hospitalier Universitaire (CHU) Lille, F-59000, Lille, France.
20
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1403, Centre Hospitalier Universitaire (CHU) Lille, University Lille, F-59000, Lille, France.
21
Service de Radiologie, Centre Hospitalier Régional Universitaire (CHRU) de Nancy, F-54000, Nancy, France.
22
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique - Centre de technologie innovante (CIC-IT) 1433, Centre Hospitalier Régional Universitaire (CHRU) de Nancy, F-54000, Nancy, France.
23
Service Imagerie Abdominale et Générale, Centre Hospitalier Universitaire (CHU) Rennes, F-35000, Rennes, France.
24
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1414, Centre Hospitalier Universitaire (CHU) Rennes, F-35000, Rennes, France.
25
Département Imagerie Médicale, Centre Hospitalier Universitaire (CHU) Tours, F-37000, Tours, France.
26
Institut national de la santé et de la recherche médicale (Inserm) Centre d'Investigation Clinique (CIC) 1415, Centre Hospitalier Universitaire (CHU) Tours, F-37000, Tours, France.
27
Service de Radiologie, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris (AP-HP), F-75475, Paris, France.
28
Clinique Universitaire de Radiologie et Imagerie Médicale, Centre Hospitalier Universitaire (CHU) de Grenoble-Alpes, F-38000, Grenoble, France.

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

PMID:
28683837
PMCID:
PMC5501074
DOI:
10.1186/s13063-017-2049-6
[Indexed for MEDLINE]
Free PMC Article

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