Safety of Bronchoscopy in Patients With Interstitial Lung Disease (SaBrILD)

University of Milan

Status: Not yet enrolling

Conditions: Pulmonary Fibrosis; Acute Exacerbation; Transbronchial Biopsy; Endosonography; Interstitial Lung Disease (ILD); Cryobiopsy; Bronchoscopy; Bronchoalveolar Lavage (BAL)

Study type: Observational

Funder types: Other

Identifiers

NCT07627594

SaBrILD

Details and patient eligibility

About

Bronchoscopy is an essential technique, routinely used in the differential diagnosis workup of many Interstitial Lung Diseases (ILDs) and in referral centres is a common procedure. Bronchoalveolar lavage (BAL), bronchial and transbronchial biopsies with forceps and cryoprobes, and lymph node sampling with endosonography represent the most used sampling techniques in these patients. However, patients with ILDs refer to medical attention in a wide range of clinical conditions from mild functional impairment, with absent or few respiratory symptoms, to severe lung involvement with low exercise tolerance and/or chronic respiratory failure. In these patients, a balance between benefits and risk, i.e. to the safety and diagnostic utility of bronchoscopy should be always carefully evaluated. Moreover, there is a wide variability in adverse events entity and frequency depending by procedures performed during bronchoscopy.

Despite its crucial utility, only few data are available in the literature on the safety of bronchoscopy in patients with ILDs and limited data on the utility and safety of this sampling technique are present in patients with AE-ILDs.

The primary aim of this study is to assess the overall rate of complications occurring within 24 hours after bronchoscopy. Study rate and type of complications occurring during the endoscopic procedure, within 30 days after bronchoscopy, in patients with AE-ILDs, among fibrotic Vs non-fibrotic ILD, and according to each employed sampling technique will be also recorded.

Enrollment: 427 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive adult (≥18 years old) patients with suspected or confirmed ILD who need to undergo bronchoscopy as part of their routine clinical practice,
• Patients able to understand and sign an informed consent

Exclusion criteria

• Patients who refused the study partecipation;
• Patients with contraindications to bronchoscopy

Trial design

427 participants in 1 patient group

Patients ≥18 years old with ILD who need to undergo bronchoscopy for diagnostic purpose

Description:

Patients ≥18 years old with interstitial lung disease who need to undergo bronchoscopy for diagnostic purposes, at the time of the first diagnosis or during follow-up (included in the work-up of an acute exacerbation).