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临床试验/CTRI/2025/07/091660
CTRI/2025/07/091660进行中(未招募)不适用

TO COMPARE THE DIAGNOSTIC YIELD OF EBUS GUIDED TBNA WITH AND WITHOUT P-ROSE IN PATIENTS WITH MEDIASTINAL LESION

NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
44
试验地点
1
主要终点
The diagnostic yield of EBUS guided TBNA with and without Rapid On-Site Evaluation by Pulmonologist (P-ROSE) in patients with mediastinal lesions

研究概览

简要总结

This is a prospective randomised study conducted at a tertiary care center in New Delhi to assess the role of Rapid On-Site Evaluation by Pulmonologist (P-ROSE) during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) in patients with mediastinal lymphadenopathy. The study aims to compare the diagnostic yield  between procedures performed with and without P-ROSE. Patients undergoing EBUS-TBNA for evaluation of mediastinal lesions will be divided into two groups: one with P-ROSE and the other without P-ROSE. Cytopathological outcomes will be analyzed to determine the impact of P-ROSE on real-time adequacy assessment and diagnostic accuracy. This study is expected to provide insights into the utility of P-ROSE in improving procedural efficiency and sample quality during EBUS.

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 99.00 Year(s)(—)
性别
All

入选标准

  • All patients aged 18 years or more with undiagnosed Mediastinal lesions who consented to participate in the study.

排除标准

  • Contra-indications of EBUS-TBNA 2) Patient unwilling to participate 3) Hemodynamic instability 4) Uncorrected coagulopathy 5) Recent myocardial infarction / unstable angina within 6 weeks.

结局指标

主要结局

The diagnostic yield of EBUS guided TBNA with and without Rapid On-Site Evaluation by Pulmonologist (P-ROSE) in patients with mediastinal lesions

时间窗: At the time of the procedure

次要结局

  • Duration of procedure between both the groups(During Procedure)
  • Dose of sedatives between both groups(During the procedure)
  • Number of jabbing between the two groups(During the procedure)
  • Number of passes between the two groups(During the procedure)
  • Distribution of cases according to histo-cytopathological examination in the two groups(After the final reporting by the pathologist (Less than 7 days))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

J K SAINI

NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES

研究点 (1)

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