The aim of this study protocol is to evaluate the feasibility of biopsies using the new system called Archimedes® in 12 patients with solitary pulmonary nodules (SPN) suspicious of malignancy not accessible through current bronchoscopy techniques.
Due to the improvement of screening techniques, the detection of peripheral and isolated lesions is an increasingly frequent situation. However these SPN cause difficulties in obtaining a sample. Indeed, current endoscopic techniques remain insufficient in terms of performance. Moreover, computed tomography-guided percutaneous needle biopsy despite a very good sensitivity has many limitations related to the size of the lesions, the accessibility and important complications. The Archimedes® system is an improved version of LungPoint® and combines 3D reconstruction of chest images with intraoperative radioscopy. It uses a catheter to access through the bronchial wall the pulmonary parenchyma and navigate to the SPN. All included patients will receive anesthesia consultation, biological assessment and chest CT scan in thin sections. A surgical treatment will always be planned after presentation of the file in a meeting of multidisciplinary consultation of thoracic oncology. The Archimedes® procedure will be performed during a bronchoscopy under general anesthesia. Immediate monitoring consisted in a chest x-ray 1hour after the procedure. Patients' participation in the study will stop once they benefit from their thoracic surgery
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
3
All patients will initially have a scanner necessary for planning by the Archimedes system of the tunneling path. each patient will then undergo a general anesthesia as for any bronchoscopy. Then start the Archimedes procedure itself to reach the SPN
CHU de Limoges
Limoges, France
Number of diagnostics obtained with the Archimedes system
It will be the biopsy yield defined as the number of patients in whom the results of nodule biopsies performed with the Archimedes® system are consistent with the surgical specimen.
Time frame: Month 1
Scheduling time of the procedure
Procedure scheduling time defined by the number of minutes elapsed between recording the patient's chest scanner on the console and when the tunneling path was examined, selected, and exported
Time frame: Day 21
Access time to the nodule
Nodule access time defined as the number of minutes elapsed between the start of navigation and the placement of the sheath within the SPN
Time frame: Day 21
Fluoroscopy time
Fluoroscopy time defined by the number of minutes the patient is exposed to ionizing radiation
Time frame: Day 21
Patient registration time
Patient recording time defined as the number of minutes required to correlate the patient's position through fluoroscopy with the navigation aid system.
Time frame: Day 21
morbi-mortality
number of hemoptysis and pneumothorax
Time frame: Month 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.