跳至主要内容
临床试验/CTRI/2024/03/064920
CTRI/2024/03/064920已完成Phase 3 4

A randomized trial to compare the diagnostic yield and patient safety profile of Thoracoscopic Flexible Forceps biopsy versus Thoracoscopic Cryo-biopsy in patients with undiagnosed Exudative Pleural Effusion

National Institute of TB and Respiratory diseases1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月10日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Diagnostic yield (whether or not diagnosis was made)

研究概览

简要总结

Pleural effusion is the abnormal excessive accumulation of fluid in the pleural cavity. Pleural effusion per se is not a diagnosis but is indicative of an underlying pathology.  It can occur by itself or can be the result of surrounding parenchymal diseases like infection, malignancy, or inflammatory conditions. Pleural effusion is one of the major causes of pulmonary mortality and morbidity.Patients with pleural effusions often present without many symptoms. Symptoms associated are pleuritic chest pain, cough, and shortness of breath. In addition, the patient will have symptoms related to the underlying cause.

In India currently, the most common cause of pleural effusion is tuberculosis (59-65%) followed by malignancy (22-25%). Parapneumonic effusion and cardiac failure constitute about 20% of total cases. However, a small portion of cases of pleural effusion remained undiagnosed even after pleural fluid examination and cell block.

Pleural biopsy via thoracoscopy is one of the most important methods of diagnosing pleural disorders. Forceps biopsies have been regularly used with semi-rigid thoracoscopy with good yield and safety. Cryo-pleural biopsy has been recently employed with semi-rigid thoracoscopy and many studies have been performed highlighting the safety and diagnostic yield.

At present only 1 RCT has been performed comparing diagnostic yield of thoracoscopic cryo versus forceps biopsy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients with undiagnosed exudative pleural effusion.

排除标准

  • Transudative effusion 2) empyema 3) haemodynamic instability.

结局指标

主要结局

Diagnostic yield (whether or not diagnosis was made)

时间窗: 5 days (duration of processing of histopathology report)

次要结局

  • change in post procedure pulse rate(1 hour post procedure)
  • change in post procedure blood pressure(1 hour post procedure)
  • comparison of tissue volume(5 days (duration of processing of histopathology report))

研究者

发起方
National Institute of TB and Respiratory diseases
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr J. K. Saini

National Institute of TB and Respiratory diseases

研究点 (1)

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