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临床试验/NCT06744946
NCT06744946已完成4 期

Comparison Between Pleurodesis by a Combination of Bleomycin and Tranxemic Acid Solution and Thoracoscopic Talc Poudrage in Malignant Pleural Effusion

Mohamed Sabry1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Dyspnea Borg Scale

研究概览

简要总结

Comparing Two Methods to Treat Fluid Build-up in Chest for Cancer Patients:Talc Powder Surgery versus Chest Tube Medicine.

详细描述

Closure of the space where the effusion is recurrently accumulated through talc poudrage in thoracoscopy or bleomycin - tranxemic acid solution injection in chest tube.

研究设计

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

入排标准

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

入选标准

  • •Adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate.
  • •Fit patients for the procedure selected.

排除标准

  • •Inability to provide informed consent for the procedure.
  • •Hemodynamically unstable patients.
  • •Bleeding diathesis.
  • •Uncontrolled cough.
  • •Hypoxic index less than
  • •Endobronchial obstruction.
  • •Pleural thickening with trapped lung.

研究组 & 干预措施

the first arm thoracoscopic talc poudrage and the second arm Bleomycin -Tranxemic mic acid mixture

Experimental

the first arm is talc insufflation through medical thoracoscopy the second arm involve bleomycin- tranxemic acid mixture injection in intercostal tube

干预措施: thoracoscope (Procedure)

结局指标

主要结局

Dyspnea Borg Scale

时间窗: one month

the rate of shortness of breath from number 0 to number 10

次要结局

未报告次要终点

研究者

发起方
Mohamed Sabry
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Sabry

Lecturer of chest diseases

Alexandria University

研究点 (1)

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