Safety of Bronchoscopy in Patients With Interstitial Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease (ILD), Bronchoscopy, Bronchoalveolar Lavage (BAL), Acute Exacerbation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety of Bronchoscopy in Patients With Interstitial Lung Disease: A Prospective, Observational, Multicentre, International Study
Overview
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.
Primary outcome measures
- Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs [Time frame: 30 days]
Secondary outcome measures (12)
- Rate and type of complications occurring during a single sampling technique or techniques combination (e.g. bronchoscopy with BAL and TBLB) [Time frame: 30 days]
- Rate and type of complications occurring within 24 hours after bronchoscopy [Time frame: 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 [Time frame: 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. [Time frame: Within 24 hours and at 30 days]
- Comparison of rate and type of complications among non-exacerbated fibrotic Vs. non-fibrotic ILDs [Time frame: 30 days]
- Difference in rate and type of complications analysed for single sampling technique using as severity scale The Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (MedDRA 28.0) [Time frame: 30 days]
- Rate and type of complications related to the respiratory support and type of sedation [Time frame: 30 days]
- Overall complications rate in patients <80 years old Vs ≥80 years old [Time frame: 30 days]
- Comparison of complications rate between patients with and without chronic respiratory failure with ILD who underwent bronchoscopy [Time frame: 30 days]
- Comparison of complications rate between patients with FVC <80% and ≥80% of predicted value [Time frame: 30 days]
- Rate and type of complications occurring during the endoscopic procedure when used for therapeutic purposes in patients with ILD [Time frame: 30 days]
- Need for respiratory support escalation following bronchoscopy [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 10 centers
- Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of M — Milan
- Respiratory Unit, Azienda Ospedaliera-Universitaria IRCCS Policlinico di Sant'Orsola Malpi — Bologna
- Unit of Pneumology, San Martino Policlinic Hospital, Genoa, Italy — Genova
- Respiratory Unit - Legnano Hospital, ASST Ovest Milanese — Legnano
- Division of Respiratory Diseases, Ospedale Luigi Sacco, Polo Universitario, ASST Fatebenef — Milan
- Respiratory Unit - Center for Rare Lung Disease - Azienda Ospedaliero-Universitaria Policl — Modena
- Respiratory Unit - IRCCS San Gerardo dei Tintori Foundation, Monza — Monza
- Interventional Pulmonology Unit, Department of Pulmonology, Oncology and Hematology, Anton — Naples
- … and 2 more centers
France · 1 center
- - Service de Pneumologie Allergologie et Transplantation, Centre Constitutif du Centre de — Paris
Identifiers
NCT: NCT07627594 · SaBrILD