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临床试验/NCT03828903
NCT03828903已完成不适用

The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion

Assiut University3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
3
主要终点
comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.

研究概览

简要总结

The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion.

详细描述

  • Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or pethidin.
  • vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space.
  • Then the trocar will be inserted until the sudden release of resistance (after passing the costal pleura) is felt.
  • Under direct vision with the thoracoscope, introduction of pneumothorax will be performed, and all pleural fluid will be removed, and the pleural cavity will be inspected.
  • Suspicious areas will be biopsied through the working channel of the thoracoscope.
  • two to six biopsies of a suspicious pleural lesion will establish the diagnosis.

Technique of pleural biopsy using cryotechnique:

  • The probe (ERBE Elektromedizin GmbH( Gesellschaft mit beschränkter Haftung) , Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.
  • The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch.
  • carbon dioxide will be used as the cryogen gas for cryobiopsy
  • The frozen tissue is going to be extracted by gently pulling of the probe.
  • Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral moderate or massive exudative pleural effusion patients.
  • Undiagnosed pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural biopsy using Abram's needle.
  • Age>18 years old

排除标准

  • Transudative pleural effusion.
  • Exudative pleural effusion less than one third of hemithorax.
  • Presence of hemorrhagic diathesis (prothrombin concentration <50% and platelet count <80,000/mm 3).
  • Poor performance state (ECOG performance status >4) as recommended in BTS (British thoracic society) guidelines
  • Sever uncontrollable cough, hypercapnia and sever respiratory distress.
  • Fibrothorax, excessive pleural adhesion.

结局指标

主要结局

comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.

时间窗: 12 months

1_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).

次要结局

  • assessment pleural fluid(12 months)
  • Complication assessment(12 months)
  • assessment of post procedure pain(12 months)

研究者

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

Alaa Salah Abd El Ghany

Assistant lecturer, Chest Department and tuberculosis

Assiut University

研究点 (3)

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