跳至主要内容
临床试验/CTRI/2024/01/061428
CTRI/2024/01/061428尚未招募Phase 3 4

Role of Medical Thoracoscopy in the evaluation of Pleural Effusion

Datta Meghe Institute of higher education and research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月12日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1. The role of thoracoscopy in patients with diagnosed and undiagnosed effusion will be assessed

研究概览

简要总结

Pleural effusion is the pathological accumulation of fluid in the pleural space surrounding the lungs and is associated with a wide variety of diseases such as bacterial pneumonia, congestive heart disease, and malignancies. Undiagnosed pleural effusion is defined as the inability to make an accurate etiologic diagnosis following an initial microscopic and biochemical examination of the pleural fluid. Medical thoracoscopy (MT) is an essential diagnostic and therapeutic procedure for multiple pleural conditions such as pleurisy, pleural effusion, and pneumothorax. It is typically carried out when multiple thoracocentesis have failed to identify the cause of the pleural effusion. The diagnostic yield is maximized by medical thoracoscopy (MT)/pleuroscopy, which enables pleural biopsy under direct view utilizing several accessible (rigid or flexi-rigid) equipment. This research aims to study the role of medical thoracoscopy in the evaluation of pleural effusion.

This hospital-based prospective and interventional study will span from July 2022 to July 2024, enrolling 50 adult patients aged 18 years and older admitted to the Department of Respiratory Medicine, a tertiary care hospital in central India. Data will be collected using a structured proforma, encompassing demographic data, clinical history, and comorbidities. Diagnostic investigations, including pleural fluid analysis, sputum analysis, and radiological assessments, will be performed upon enrolment. The patients having undiagnosed pleural effusion will undergo a medical thoracoscopy after taking informed consent. The purpose of the study is to describe the diagnostic efficacy of thoracoscopy and to correlate its findings to pleural fluid parameters.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Adult (18 years and above) patients with pleural effusion admitted to the Department of Respiratory Medicine at AVBRH.

排除标准

  • 1.Patient unfit for undergoing thoracoscopy 2.Patients that deny consent to participate in the study.

结局指标

主要结局

1. The role of thoracoscopy in patients with diagnosed and undiagnosed effusion will be assessed

时间窗: 2-4 weeks

2. The efficacy of medical thoracoscopy in the diagnosis of pleural effusion will be studied

时间窗: 2-4 weeks

3. Correlation will be determined between findings of medical thoracoscopy with biochemical and cytological parameters of pleural fluid.

时间窗: 2-4 weeks

次要结局

  • not applicable(not applicable)

研究者

发起方
Datta Meghe Institute of higher education and research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Anjana Ledwani

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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