Bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
Conditions
Keywords
bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
Brief summary
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.
Detailed description
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
Interventions
DEVICEArchimedes procedure
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
Sponsors
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 to 75 years with a suspicious nodule of malignancy (primary lung tumor or metastasis of another solid tumor whose largest diameter is greater than or equal to 8 mm): * Not associated with endobronchial tumor visible during inspection of tracheobronchial tree with soft bronchoscope * Located in any part of the lung more than 10mm from the pleura * For which surgical management (atypical resection, lobectomy, bilobectomy or pneumonectomy) is planned after presentation of the file at a multidisciplinary consultation meeting on thoracic oncology of the Investigating Hospital Center * Patient able to understand the course of the study and giving informed consent * Affiliate or beneficiary of a social security scheme
Exclusion criteria
* Threatening cardiac arrhythmias defined by a rhythm disorder dating discovered less than a month ago * Myocardial infarction less than one month old * Hypercapnic respiratory decompensation less than one month old * coagulopathy * Thrombocytopenia with platelet count \<100,000 / mm3 * Antecedent (ATCD) of significant bleeding during previous bronchoscopy * ATCD of pulmonary arterial hypertension (PAH) or suspicion of PAH defined by a measurement of systolic pulmonary arterial pressure greater than 50 mmHg on echocardiography (this examination is not systematic but the suspicion of PAH on the thoracic CT scan leads to other cardiac echocardiographic examinations or right heart catheterization in case of inconclusive ultrasound) * ATCD of pneumonectomy * Giant bubble\> 5cm located near the nodule or the tunneling path * Inability to stop anticoagulant or antiplatelet therapy before the procedure (taking acetylsalicylic acid at any dose is allowed) * Pregnant or lactating woman * ATCD for thoracic radiotherapy on the nodule side * Patient under tutorship or curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of diagnostics obtained with the Archimedes system | Month 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scheduling time of the procedure | Day 21 | 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 |
| Access time to the nodule | Day 21 | Nodule access time defined as the number of minutes elapsed between the start of navigation and the placement of the sheath within the SPN |
| Fluoroscopy time | Day 21 | Fluoroscopy time defined by the number of minutes the patient is exposed to ionizing radiation |
| Patient registration time | Day 21 | Patient recording time defined as the number of minutes required to correlate the patient's position through fluoroscopy with the navigation aid system. |
| morbi-mortality | Month 1 | number of hemoptysis and pneumothorax |
Countries
France
Outcome results
None listed