Safety of Bronchoscopy in Patients With Interstitial Lung Disease

Sponsor
University of Milan
Study ID
NCT07627594
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
427 participants (estimated)

Arms

  • Arm: Patients ≥18 years old with ILD who need to undergo bronchoscopy for diagnostic purpose
    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).

Primary Outcome Measure

Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs [ Time Frame: 30 days ]

Central Contacts

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