跳至主要内容
临床试验/NCT06964321
NCT06964321尚未招募不适用

Effectiveness of Intercostal Tube Drainage Vs Pigtail Catheter Drainage Vs Ultrasound-Guided Aspiration in Management of Massive Malignant Pleural Effusion

Assiut University0 个研究点目标入组 66 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
Resolution of Pleural Effusion

研究概览

简要总结

Pleural effusion is common in different diseases and especially malignant effusions can have fast onset symptoms such as chest pain, dyspnoea, and coughing. Malignant pleural effusion (MPE) is an exudative effusion with malignant cells.

It is a common symptom and accompanying presentation of metastatic disease. It Impacts up to 15% of all patients with cancer and is the most common in breast, lung, cancer, lymphoma, and gynaecological malignancies . There are 150,000 new cases of MPE in the United States yearly and 100,000 in Europe . Patients have an overall survival (OS) rate of 3-12 months after the initial diagnosis . Malignant pleural effusion (MPE) poses significant challenges in management, impacting patient quality of life and overall prognosis. Almost all radiological procedures can help diagnose pleural effusions . Thoracentesis is used as a diagnostic and therapeutic tool. The procedure has been modified with the addition of ultrasound, that is very functional for targeting certain anatomical areas of the pleura and finding an appropriate entry point . Three primary strategies are commonly employed: intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration. This study aims to evaluate these methods' efficacy, safety, and outcomes. To compare intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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 patient aged 18 years old and above.
  • •Patients diagnosed with massive malignant pleural effusion (MPE) requiring intervention.

排除标准

  • •Pediatric patients aged below 18 years
  • •Patients with non-malignant causes of pleural effusion.

研究组 & 干预措施

Group A

Active Comparator

intercostal tube drainage in managing massive malignant pleural effusion (MPE).

干预措施: intercostal tube drainage (Procedure)

Group B

Active Comparator

big tail catheter drainage in managing massive malignant pleural effusion (MPE).

干预措施: big tail catheter drainage (Procedure)

Group C

Active Comparator

ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).

干预措施: ultrasound-guided aspiration (Procedure)

结局指标

主要结局

Resolution of Pleural Effusion

时间窗: baseline

Resolution of Pleural Effusion: Defined as complete or partial resolution based on imaging studies (e.g., chest X-ray or ultrasound).

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

Mark Badrat William Mansour

residant doctor

Assiut University

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