Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

Lung Cancer Clinical Trial

Official title: Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lung Cancer

• NCT number: NCT04029155
• Study type: Interventional
• Source: Università Politecnica delle Marche
• Contact: Stefano Gasparini, Professor
• Phone: 071-5964352
• Email: s.gasparini@univpm.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Completion date: June 1, 2023