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临床试验/NCT06691009
NCT06691009尚未招募不适用

Effectiveness of Pleurodesis by Pleural Abrasion Using Medical Thoracoscopy Versus Bleomycin Via Pleural Catheter in Patients With Malignant Pleural Effusion

Assiut University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
2
主要终点
Assessment of successful pleurodesis by chest ultrasound

研究概览

简要总结

Comparision between pleurodesis by pleural abrasion using medical thoracoscopy and bleomycin instillation via indwelling pleural catheter. Evaluating the effectiveness of pleural abrasion using medical thoracoscopy in patients with malignant pleural effusion and evaluating the role of ROSE in diagnosis and management of malignant pleural effusion

详细描述

Malignant pleural effusion cause significant morbidity so drainage effusion can provide great palliation and improve quality of life of these patients. There are several diagnostic tools for diagnosing malignant pleural effusion as pleural fluid cytology, closed pleural biopsy or thoracosopic pleural biopsy. Medical thoracoscopy has significant role in diagnosis and management of malignant pleural effusion. Also, pleurodesis may be performed through it by mechanical methods as pleural abrasion or chemical methods by talc poudrage, bleomycin or cisplatin instillation . and surgically through pleurectomy. Recently, using of ROSE (Rapis On-Site Examination) technique during medical thoracoscopy showed high accuracy for distinguishing between benign and malignant lesions, and this help in decision making. In our study, we will use mechanical pleurodesis by pleural abrasion using medical thoracoscpy and chemical pleurodesis by instillation of bleomycin via indwelling pleural catheter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

There will be an outcome assessor who do not know which group recieved which treatment. Also, the participants will not know to which group they will be included.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are 18 years old or more.
  • patients with rapidly accumulating moderate & massive malignant pleural. effusion that need frequent aspiration to relieve dyspnea and affect quality of life of the patient.

排除标准

  • patients not fit for thoracoscoy.
  • patients with life expectency less than 1 month .
  • trapped lung (endobronchial lesion).
  • excessive pleural adhesios.
  • mild effusion not need frequent aspiration and not affect
  • quality of life .
  • patients with chest infection : pneumonia , empyema .
  • patients with performance status that doesn't expected to increase by 1

结局指标

主要结局

Assessment of successful pleurodesis by chest ultrasound

时间窗: 6 months

This will be done every 2 weeks to detect any recollection of fluid in the pleural space. It will be used to determine whether the intervention achieved full or partial success

次要结局

未报告次要终点

研究者

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

Asmaa Mahmoud Mohammed Eltayeb

Assistant lecturer of chest diseases

Assiut University

研究点 (2)

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