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临床试验/NCT06742099
NCT06742099尚未招募1 期

Outcome of Intercostal Tube Insertion and Pleurodesis for Malignant Pleural Effusion

Assiut University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月30日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
chest imaging, chest x-rays will be used to record the progress of the malignant pleural effusion in both treatments

研究概览

简要总结

Approximately half of all patients with metastatic cancer develop a malignant pleural effusion which is likely to lead to a significant reduction in quality of life secondary to symptoms such as dyspnoea and cough. The aim of pleurodesis in these patients is to prevent re-accumulation of the effusion and thereby of symptoms,and avoid the need for repeated hospitalization for thoracocentesis. Numerous clinical studies have been performed to try to determine the optimal pleurodesis strategy, and synthesis of the available evidence should facilitate this. The treatment of MPE is aimed at palliating symptoms since no intervention has been shown to improve survival in this population and since survival is generally limited in cancers that have spread to the pleural space. In this palliative setting, only patients symptomatic from their MPE should be submitted to further intervention. As well, further interventions in symptomatic patients should be limited to those patients who have experienced symptomatic improvement following initial therapeutic thoracentesis. The two main treatment approaches to MPE are to obliterate the pleural space via a pleurodesis procedure or to chronically drain the pleural cavity with Intercostal tube. The aims of this review were to ascertain the optimal procedure in cases of malignant pleural effusion in terms of patients' quality of life post procedure, recurrence of effusion.

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

性别
All
接受健康志愿者
否

入选标准

  • •All patients presented with malignant pleural effusion to Assiut University Hospital regardless of sex and age

排除标准

  • •All patients presented with pleural effusion other than malignant pleural effusion, including patients with debilitating diseases and terminal patients.

研究组 & 干预措施

Malignant Pleural effusion with pleurodesis

Active Comparator

these are patients who have malignant pleural effusion and will have talc injected into the pleural cavity to induce pleurodesis

干预措施: Intercostal chest tube (Procedure)

Malignant Pleural effusion with pleurodesis

Active Comparator

these are patients who have malignant pleural effusion and will have talc injected into the pleural cavity to induce pleurodesis

干预措施: Pleurodesis (Combination Product)

Malignant Pleural effusion with only chest tube for drainage

Active Comparator

these are patients who have malignant pleural effusion but will only have intercostal chest tube inserted for drainage

干预措施: Intercostal chest tube (Procedure)

结局指标

主要结局

chest imaging, chest x-rays will be used to record the progress of the malignant pleural effusion in both treatments

时间窗: from the time of intervention up to 6 months

efficacy of both treatments, in which the treatment that shows less accumulation of pleural effusion in chest imaging gets better results hence is more effective than the other in terms of reducing Malignant Pleural effusion

A questionnaire will be used to assess tolerability of both treatments on patients

时间窗: from the time of intervention up to 6 months

Tolerability, in which the questionnaire will include a score from 1 to 10 in which 1 is the lowest point and 10 is the highest point, it will include how painful each treatment is and how quality of life has changed after each treatment

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

Hussein Essameldin Hussein Mohamed

Assistant Lecturer

Assiut University

研究点 (1)

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