Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Stefano Gasparini
- Enrollment
- 142
- Primary Endpoint
- Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm
Study Overview
Brief Summary
This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.
Detailed Description
142 patients with at least one peripheral pulmonary nodule will be enrolled. They will underwent randomization in 2 arms: patients in the first arm will undergo transbronchial needle aspiration with a conventional bronchoscope patients in the second arm will undergo transbronchial needle aspiration with a ultra-thin bronchoscope. Every bronchoscopy will be performed by the same operator and will contemplate 3 passes for each nodule, followed by Rapid On-Site Evaluation (ROSE) assessed by a dedicated cytologist. If the cytological on-site evaluation is negative in patients in the first arm, they will be shifted to the second arm. Histological and molecular diagnosis will be assessed by a dedicated pathologist. Data will be collected and analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥ 18years;
- •presence of at least one peripheral pulmonary lesion ≤ 3 cm on CT scan;
- •ability to give an informed consent.
Exclusion Criteria
- •coagulopathy or bleeding diathesis that cannot be corrected;
- •severe refractory hypoxemia;
- •unstable hemodynamic status;
- •inability to give an informed consent.
Arms & Interventions
TBNA with Conventional bronchoscope
patients in this arm will undergo bronchoscopy by a conventional probe
Intervention: Lung biopsy (Device)
TBNA with a Ultrathin bronchoscope
Patients in this arm will undergo bronchoscopy by a ultra thin probe
Intervention: Lung biopsy (Device)
Outcomes
Primary Outcomes
Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm
Time Frame: through study completion, an average of 6 months
percentage
Secondary Outcomes
- Assess if diagnostic yield is higher in the "ultrathin" arm than in the "conventional" arm(through study completion, an average of 6 months)
Investigators
Stefano Gasparini
Professor
Università Politecnica delle Marche