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

Autor: I. Bricault, S. Pottier, S. Aubry, R. C. Rouchy, Mostafa El Hajjam, F. Patat, E. de Kerviler, G. Kervio, M. Durand, X. Orry, R. Logier, A. Cherifi, B. Renard, E. Chipon, A. Moreau-Gaudry, M. Medici, J. Ghelfi, O. Favelle, C. Hughes, Lionel Pazart, B. Lapuyade, E. Quehen, A. Mounier
Přispěvatelé: Centre d'Investigation Clinique - Innovation Technologique - INSERM - CHU de Grenoble (CIC-IT Grenoble (CIT803)), CHU Grenoble-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Bordeaux [Bordeaux], CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Ambroise Paré [AP-HP], Centre d’Investigation Clinique 1429 [Garches] (CIC 1429), Hôpital Raymond Poincaré [AP-HP]-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service central de radiologie et d'imagerie médicale, CHU Grenoble-Hôpital Michallon, This trial is funded by the French Ministry of Health as part of the Hospital Clinical Research Program (PHRC-N 2012)., Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Time Factors
Percutaneous
Active Comparator
[SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging
Medicine (miscellaneous)
Radiography
Interventional
030218 nuclear medicine & medical imaging
law.invention
Study Protocol
0302 clinical medicine
Clinical Protocols
Randomized controlled trial
law
Electromagnetic navigation
Abdomen
Pharmacology (medical)
Prospective Studies
Medical device
lcsh:R5-920
medicine.diagnostic_test
Interventional radiology
Equipment Design
Radiation Exposure
Thorax
3. Good health
Needles
Research Design
030220 oncology & carcinogenesis
Radiographic Image Interpretation
Computer-Assisted
France
Computer-assisted medical intervention
lcsh:Medicine (General)
Electromagnetic Phenomena
medicine.medical_specialty
IMACTIS-CT®
Subgroup analysis
Punctures
Radiation Dosage
Imaging guidance
03 medical and health sciences
Computed Tomography
Predictive Value of Tests
medicine
Humans
Medical physics
Minimally invasive
Protocol (science)
business.industry
Navigation system
Surgery
Clinical trial
Tomography
X-Ray Computed
business
Software
Zdroj: Trials
Trials, 2017, 18 (1), pp.306. ⟨10.1186/s13063-017-2049-6⟩
Trials, Vol 18, Iss 1, Pp 1-11 (2017)
Trials, BioMed Central, 2017, 18 (1), pp.306. ⟨10.1186/s13063-017-2049-6⟩
ISSN: 1745-6215
Popis: 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2049-6) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
Externí odkaz: