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临床试验/NCT00720954
NCT00720954已完成不适用

Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial

Eskisehir Osmangazi University2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
2
主要终点
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases

研究概览

简要总结

The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.

详细描述

Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is between 7 % -72 %, ~ 50 %. Problems for Abrams needle are scattered tumoral involvement on pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and usually involvement of lower pleural surface and diaphragmatic pleura.

Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if done with image guided and if this increase the diagnosis rate, the number of second procedure which is more expensive and hard will decrease.

The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.

It has been planned that a total of 120 patients accepted to the study who have pleural effusion at plain chest roentgenogram. All patients are being randomized after underwent contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and undiagnosed patients of thoracoscopy group followed up.

Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and complication rate.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Diagnostic

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages between 18-85
  • Pleural effusion in conventional radiography
  • At least 10x10 cm space in pleural space with effusion
  • No bleeding diathesis
  • Informed consent

排除标准

  • Patients who went under pleural biopsy before
  • Hypertensive attack during biopsy
  • Bleeding diathesis

结局指标

主要结局

Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases

时间窗: 30 months

次要结局

  • Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.(30 months)

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other

研究点 (2)

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