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临床试验/NCT07432503
NCT07432503已完成不适用

Diagnostic Yield and Safety of Transbronchial Lung Biopsy With Forceps,Cryo-biopsy or Thoracoscopic Lung Biopsy in Interstitial Lung Diseases

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Diagnostic Yield of Different Lung Biopsy Techniques

研究概览

简要总结

This study aims to evaluate the diagnostic yield and safety of different lung biopsy techniques in patients with interstitial lung diseases (ILD). The study compares transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and thoracoscopic lung biopsy in terms of their ability to provide accurate diagnosis and associated complications. Interstitial lung diseases represent a heterogeneous group of diffuse parenchymal lung disorders that often require histopathological confirmation. This study will help determine the most effective and safest biopsy technique to improve diagnostic accuracy and patient outcomes.

详细描述

Interstitial lung diseases (ILD) are a diverse group of diffuse parenchymal lung disorders characterized by inflammation and fibrosis. Accurate diagnosis is essential for appropriate management and prognosis. Lung biopsy is often required when clinical and radiological findings are inconclusive. Several biopsy techniques are available, including transbronchial lung biopsy using forceps, transbronchial cryobiopsy, and surgical thoracoscopic lung biopsy.

Transbronchial forceps biopsy is widely available but may have limited diagnostic yield due to small specimen size. Cryobiopsy provides larger tissue samples with better preservation of lung architecture, potentially improving diagnostic accuracy. Thoracoscopic lung biopsy is considered the gold standard but is more invasive and associated with higher risk.

This study aims to compare the diagnostic yield and safety profile of these biopsy techniques in patients with suspected interstitial lung diseases. The results of this study may help guide clinicians in selecting the most appropriate biopsy technique while minimizing complications.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age more than 18 years
  • patients with no absolute contraindications for procedure
  • cases who had clinical, laboratory and radiological criteria of ILD

排除标准

  • patients with images typical of definite UIP and definite extrinsic allergic alveolitis
  • clinical and radiological evidence of occupational lung diseases
  • coagulation disorder, advanced uncompensated heart disease, uncompensated Type II Respiratory failure, severe grades of pulmonary hypertension
  • pulmonary metastasis or lymphangitis carcinomatosis
  • specific parenchymal pattern "honeycombing, probable UIP, diffuse end stage fibrosis, cystic lung diseases and advanced LAM and PLCH

研究组 & 干预措施

forceps biopsy

Experimental

patients undergo bronchoscopic transbronchial forceps biopsy

干预措施: Transbronchial forceps biopsy (Procedure)

Cryobiopsy

Active Comparator

Patients undergo bronchoscopic transbronchial cryobiopsy using a cryoprobe to obtain lung tissue samples for histopathological diagnosis

干预措施: transbronchial cryobiopsy (Procedure)

Thoracoscopic biopsy

Active Comparator

Surgical thoracoscopic procedure to obtain lung tissue samples

干预措施: thoracoscopic lung biopsy (Procedure)

结局指标

主要结局

Diagnostic Yield of Different Lung Biopsy Techniques

时间窗: At time of biopsy procedure(day 0)

Diagnostic yield defined as the proportion of biopsy procedures providing a definitive histopathological diagnosis in patients with interstitial lung diseases

次要结局

  • Complication Rate of Lung Biopsy Techniques(Within 30 days after the biopsy procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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