Safety of Bronchoscopy in Patients With Interstitial Lung Disease

NCT07627594 | Not Yet Recruiting

• 1 other identifier: SaBrILD
• Study Type: observational
• Target: 427
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

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

Keywords

ILD; BAL; acute exacerbation; cryobiopsy; transbronchial biopsy; interstitial lung disease; pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs

  To assess the overall rate of complications occurring 30 days after bronchoscopy in patients with Interstitial Lung Diseases undergoing the endoscopic examination for diagnostic purposes, at the time of the first diagnosis or during follow-up (included in the work-up of an acute exacerbation).

  30 days

Secondary Outcomes (17)

• Rate and type of complications occurring during a single sampling technique or techniques combination (e.g. bronchoscopy with BAL and TBLB)

  30 days

• Rate and type of complications occurring within 24 hours after bronchoscopy

  24 hours

• Rate and type of complications occurring during the endoscopic procedure, within 24 hours and 30 days after bronchoscopy, at the time of the first ILD diagnosis Vs. during the follow-up

  Within 24 hours and at 30 days

• Rate and type of complications occurring during the endoscopic procedure, within 24 hours and 30 days after bronchoscopy in case of suspected/diagnosed AE.

  Within 24 hours and at 30 days

• Comparison of rate and type of complications among non-exacerbated fibrotic Vs. non-fibrotic ILDs

  30 days

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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). During the study period, individual patients may undergo more than one bronchoscopic procedure (e.g., for initial diagnostic purposes or for subsequent clinical indications such as disease exacerbation). Therefore, each procedure will be considered as a separate observation for safety analysis.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (11)

- Service de Pneumologie Allergologie et Transplantation, Centre Constitutif du Centre de Référence des Maladies Pulmonaires Rares, FHU INFIRE, Paris, France

Paris, 75877, France

Location

Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy), Milano, Lombardia 20142

Milan, Lombardy, 20162, Italy

Location

Respiratory Unit, Azienda Ospedaliera-Universitaria IRCCS Policlinico di Sant'Orsola Malpighi, Bologna, Italy

Bologna, 38050, Italy

Location

Unit of Pneumology, San Martino Policlinic Hospital, Genoa, Italy

Genova, 16132, Italy

Location

Respiratory Unit - Legnano Hospital, ASST Ovest Milanese

Legnano, 20025, Italy

Location

Division of Respiratory Diseases, Ospedale Luigi Sacco, Polo Universitario, ASST Fatebenefratelli-Sacco

Milan, 20157, Italy

Location

Respiratory Unit - Center for Rare Lung Disease - Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy

Modena, 41124, Italy

Location

Respiratory Unit - IRCCS San Gerardo dei Tintori Foundation, Monza

Monza, 20900, Italy

Location

Interventional Pulmonology Unit, Department of Pulmonology, Oncology and Hematology, Antonio Cardarelli Hospital, Naples, Italy

Naples, 80131, Italy

Location

Unit of Respiratory Medicine "L. Vanvitelli", A.O. dei Colli, Monaldi Hospital, Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy

Naples, 80138, Italy

Location

Respiratory Unit, Santa Maria alle Scotte University Hospital, Siena

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Mondoni, MD

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Mondoni, MD

CONTACT

+39 0281843025; michele.mondoni@unimi.it

Jacopo Cefalo, MD

CONTACT

+39 0281843025; michele.mondoni@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associated Professor of Respiratory Medicine

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

FR (1); IT (10)