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临床试验/NCT07130110
NCT07130110已完成不适用

Diagnostic Contribution of Bronchoalveolar Lavage to Lung Cryotransbronchial Biopsy in Interstitial Lung Diseases

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2023年12月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
1
主要终点
Diagnostic Yield of c-TBB

研究概览

简要总结

The goal of this observational study is to evaluate whether performing bronchoalveolar lavage (BAL) simultaneously with transbronchial lung cryobiopsy (c-TBB) can improve diagnostic yield in adult patients with suspected interstitial lung disease (ILD).

The main questions it aims to answer are:

  • Does the addition of BAL to c-TBB increase the overall diagnostic accuracy in ILD patients?
  • Can the combination of BAL and c-TBB reduce the need for surgical lung biopsy in the diagnostic process of ILD?

If there is a comparison group: Researchers will compare patients diagnosed by c-TBB alone to those evaluated with both c-TBB and BAL to see if BAL provides additional diagnostic value, especially in cases where histopathological findings from c-TBB are inconclusive.

Participants will:

Undergo transbronchial lung cryobiopsy (c-TBB) under general anesthesia to collect lung tissue samples.

Have bronchoalveolar lavage (BAL) performed in the same session using ATS guideline-based protocols.

Be evaluated in a multidisciplinary discussion (MDD) integrating clinical, radiologic, and pathologic findings to establish a final diagnosis.

详细描述

Interstitial Lung Diseases (ILDs) are a rare group of diseases characterized by inflammation and fibrosis of the lung interstitium, with many subtypes. The incidence is reported as approximately 75 per 100,000 in the US and Europe, and 25.8 in Turkey. ILDs are classified into known causes, idiopathic interstitial pneumonias (IIPs), granulomatous diseases, and other subgroups.

While surgical lung biopsy remains the gold standard for diagnosis, it carries risk of complications. Therefore, cryobiopsy (c-TBB), a minimally invasive method, is preferred, with diagnostic yield ranging between 50-90%.

Bronchoalveolar lavage (BAL) provides cellular analysis from the alveoli, aiding differential diagnosis in ILD but is limited as a sole diagnostic tool. Combined use of c-TBB and BAL may improve diagnostic accuracy and reduce the need for surgical biopsy.

In this study, the diagnostic contribution of simultaneous BAL in patients undergoing c-TBB with a preliminary ILD diagnosis was investigated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
19 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients over the age of 18,
  • Patients diagnosed with interstitial lung disease through imaging methods, and patients who underwent cryotransbronchial biopsy and bronchoalveolar lavage

排除标准

  • Being under 18 years of age,
  • Patients diagnosed with malignancy,
  • Patients who underwent non-standardized bronchoalveolar lavage,
  • Patients whose data are unavailable

结局指标

主要结局

Diagnostic Yield of c-TBB

时间窗: Within 1 week after the procedure

The proportion of patients in whom a histopathological diagnosis was established using transbronchial cryobiopsy (c-TBB).

次要结局

  • Procedure-Related Complications of c-TB(Within 48 hours after the procedure)
  • Contribution of BAL to Multidisciplinary Diagnosis (MDD)(Within 1 month of the procedure)
  • Diagnostic Yield of Multidisciplinary Discussion in c-TBB-Negative Cases(Within 1 month of the procedure)

研究者

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

ERDOGAN CETINKAYA

Prof. Dr.

Saglik Bilimleri Universitesi

研究点 (1)

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