Conventional vs Ultrathin Bronchoscopy for Peripheral Pulmonary Lesions

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04029155

Enrollment

142

Registered

2019-07-23

Start date

2022-07-01

Completion date

2023-06-01

Last updated

2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

peripheral pulmonary nodules, ultrathin bronchoscope, transbronchial needle aspiration

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.

Interventions

DEVICELung biopsy

Transbronchial Needle Aspiration performed via a ultra thin bronchoscope

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Assess if sensitivity is higher in the ultrathin arm than in the conventional arm	through study completion, an average of 6 months	percentage

Secondary

Measure	Time frame	Description
Assess if diagnostic yield is higher in the ultrathin arm than in the conventional arm	through study completion, an average of 6 months	percentage

Other

Measure	Time frame	Description
Assess if sensitivity is similar in both arms	through study completion, an average of 6 months	percentage

Contacts

Primary ContactStefano Gasparini, Professor

s.gasparini@univpm.it071-5964352

Backup ContactMartina Bonifazi, Professor

m.bonifazi@staff.univpm.it071-5965538

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026