Safety of Bronchoscopy in Patients With Interstitial Lung Disease

Официальное название

Safety of Bronchoscopy in Patients With Interstitial Lung Disease: A Prospective, Observational, Multicentre, International Study

Обзор

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.

Первичные конечные точки

• Overall rate of complications occurring 30 days after bronchoscopy in patients with ILDs [Срок оценки: 30 days]

Вторичные конечные точки (12)

• Rate and type of complications occurring during a single sampling technique or techniques combination (e.g. bronchoscopy with BAL and TBLB) [Срок оценки: 30 days]
• Rate and type of complications occurring within 24 hours after bronchoscopy [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Within 24 hours and at 30 days]
• Comparison of rate and type of complications among non-exacerbated fibrotic Vs. non-fibrotic ILDs [Срок оценки: 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) [Срок оценки: 30 days]
• Rate and type of complications related to the respiratory support and type of sedation [Срок оценки: 30 days]
• Overall complications rate in patients <80 years old Vs ≥80 years old [Срок оценки: 30 days]
• Comparison of complications rate between patients with and without chronic respiratory failure with ILD who underwent bronchoscopy [Срок оценки: 30 days]
• Comparison of complications rate between patients with FVC <80% and ≥80% of predicted value [Срок оценки: 30 days]
• Rate and type of complications occurring during the endoscopic procedure when used for therapeutic purposes in patients with ILD [Срок оценки: 30 days]
• Need for respiratory support escalation following bronchoscopy [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 10 центров

• 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
• … и ещё 2 центра

Франция · 1 центр

• - Service de Pneumologie Allergologie et Transplantation, Centre Constitutif du Centre de — Paris

Идентификаторы

NCT: NCT07627594 · SaBrILD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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