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临床试验/NCT07627594
NCT07627594尚未招募不适用

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

University of Milan11 个研究点 分布在 2 个国家目标入组 427 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
427
试验地点
11

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Mondoni

MD, Associated Professor of Respiratory Medicine

University of Milan

研究点 (11)

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