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临床试验/NCT04932811
NCT04932811招募中不适用

The Lung Microbiome in Patients With Emphysema and Chronic Obstructive Lung Disease Treated With Endobronchial Valves: Complications and Prognosis

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Valve dysfunction

研究概览

简要总结

Lung emphysema is often associated with chronic obstructive pulmonary disease (COPD) and without any cure. Dyspnea is the main, debilitating symptom and is relieved by inhaled bronchodilators and rehabilitation. However, a substantial number of patients continue to suffer from dyspnea and among these, many patients have severely hyperinflated lungs due to predominant emphysema. For selected patients, lung transplantation or lung volume reduction by surgical removal (LVRS) of the most emphysematous parts of the lung can improve symptoms and survival. However, LVRS is related to complications and not all patients are suitable for surgery. An alternative to LVRS is bronchial lung volume reduction with endobronchial valves (EBV). One-way valves are inserted in the bronchial system using a bronchoscope and it has emerged as a valid treatment option with similar effects as LVRS with reduction of hyperinflation and increasing pulmonary function, quality of life, and exercise capacity.

The normal lung is colonized with several types of bacteria, and together this is called the microbiome. Some bacteria are potentially beneficial, while others are potentially harmful. After the insertion EBV, some patients develop chronic infections. The hypothesis is that the microbiome can affect the risk of this chronic infection, and therefore the objective of this study is to access the microbiome during the insertion of the EBV, and afterwards observe which patients develop chronic infection and if these patients are harbouring specific types of bacteria.

详细描述

The objective of this study is primarily to investigate the significance of the lung microbiome on the outcome and morbidity after EBV treatment. Second, to investigate the evolution of the lung microbiome in patients later requiring valve removal or clean-up.

Before the insertion of the EBV, but during the procedure, the patient will undergo a bronchoalveolar lavage (BAL). BAL fluid will undergo bacterial profiling through S16-ribosomal analysis and ordinary bacterial culturing. Number of infections and need for clean-up or valve removal will be registered during the following 24 months, where the patient follows the ordinary follow-up programme. As a secondary part of the study, during the potential clean-up or valve removal, the removed material will again undergo S16-ribosomal analysis and bacterial culturing to investigate shift in microbiome.

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

  • COPD patients with emphysema selected for EBV treatment by multidiciplinary team, independent of this study.
  • Written informed consent

排除标准

  • Intake of oral antibiotics within 1 month before the procedure. Patients receiving preventive long-term treatment with antibiotics can be included.

结局指标

主要结局

Valve dysfunction

时间窗: 2 years

Dysfunction of valves requiring clean up

Microbiome

时间窗: During surgery

Microbiome in bronchioalveolar lavage

Pulmonary infection

时间窗: 2 years

Number and severity of pulmonary infection after surgery

次要结局

  • Formation of atelectasis(2 years)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirstine Hermann

Cand. med.

Aarhus University Hospital

研究点 (1)

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