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临床试验/NCT06159023
NCT06159023招募中不适用

Bronchoalveolar Lavage Using a Conventional Bronchoscope vs. Bronchial Washing Using a Thin Bronchoscope to Diagnose Pulmonary Tuberculosis: a Prospective Randomized Trial

Pusan National University Hospital2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2023年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
132
试验地点
2
主要终点
TB detection rate

研究概览

简要总结

This study aims to compare the diagnostic yield of bronchoalveolar lavage (BAL) using a thick conventional bronchoscope and bronchial washing (BW) using a thin bronchoscope in the diagnosis of pulmonary tuberculosis.

详细描述

In patients with suspected pulmonary tuberculosis (TB), confirm the presence of TB bacilli through sputum testing is essential for diagnosis. However, the sensitivity of sputum specimens is suboptimal, and some patients may be unable to produce sputum. In such situations, it is traditionally known that obtaining samples through bronchoscopy increases the diagnostic yield of pulmonary TB. Typically, the method of using a thick, conventional bronchoscope to perform bronchial washing (BW) or bronchoalveolar lavage (BAL) is commonly employed. However, a drawback of the conventional bronchoscope is its inability to reach close to peripheral pulmonary TB lesions due to its larger diameter.

Recent studies have reported an increased diagnostic yield for pulmonary TB when using a thin bronchoscope for BW compared to using a thick, conventional bronchoscope for BW. However, a direct comparison with the method of performing BAL (BAL may have a higher diagnostic yield compared to BW) using a conventional bronchoscope has not been conducted. This study aims to prospectively compare the diagnostic yield for pulmonary TB between BAL using a conventional bronchoscope and BW using a thin bronchoscope.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

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

  • participants age > 17 years with suspected pulmonary TB
  • possible active pulmonary TB evident on chest radiography or CT scan
  • negative AFB smear results (using two consecutive self-expectorated sputum)
  • negative TB-PCR results (using one self-expectorated sputum)
  • inability to produce self-expectorated sputum

排除标准

  • a request for empirical TB treatment rather than bronchoscopy
  • suspect pulmonary TB lesions that are difficult to target for BAL or BW (e.g., multiple discrete tiny nodules)
  • contra-indication of bronchoscopy (e.g., bleeding tendency, hypoxemia requiring oxygen, or uncontrolled cardio/cerebrovascular disease)

结局指标

主要结局

TB detection rate

时间窗: within 2 weeks of bronchoscopy

Positivity rate of Xpert MTB/RIF assay in BAL or BW fluid

次要结局

  • Mycobacterium tuberculosis culture(within 8 weeks of bronchoscopy)
  • Adverse event(within 2 weeks of bronchoscopy)
  • AFB(acid-fast bacilli) smear(within 2 weeks of bronchoscopy)
  • Time to treatment(within 8 weeks of bronchoscopy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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