Clinical trial NCT04029155: Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions
Official title: Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: peripheral pulmonary nodules
ultrathin bronchoscope
transbronchial needle aspiration
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Assess if diagnostic yield is higher in the "ultrathin" arm than in the "conventional" arm
timeFrame: through study completion, an average of 6 months
Other outcomes:
measure: Assess if sensitivity is similar in both arms
timeFrame: through study completion, an average of 6 months
Locations:
Study officials:
References:
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