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临床试验/NCT04306614
NCT04306614已完成不适用

Capillary Versus Suction Needle Aspiration for Rapid Onsite Cytologic Evaluation in Endobronchial Ultrasound Biopsies

Western University, Canada1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
118
试验地点
1
主要终点
Procedure Duration

研究概览

简要总结

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration is a procedure used to obtain tissue samples (biopsies) of lymph nodes near the airways or of lung tumours growing in close proximity to the airways. Briefly, an endoscope with an ultrasound probe which is inserted through the mouth and into the airways. Once in the airways, the ultrasound allows for identification of the optimal biopsy site; a hollow biopsy needle is then inserted into the tissue under real-time ultrasound visualization and a sample is extracted.

In the investigator's centre, the extracted sample is then immediately subjected to rapid on-site evaluation (ROSE). During the ROSE procedure, a cytotechnologist uses part of the sample to make a limited number direct smears which are then rapidly stained and evaluated under a microscope by the cytotechnologist. The cytotechnologist provides an assessment of the adequacy of the sample for diagnosis. The respirologist performing the EBUS then uses this information to: i) determine whether additional sampling is required, and ii) triage any additional samples for ancillary studies as needed. A final cytopathological diagnosis is established several days later, when all of the material from the procedure (including the material not evaluated at ROSE) is examined by a cytopathologist.

There are different techniques which are utilized to perform the needle aspiration biopsy. Suction aspiration (where pressure suction is applied to the needle to draw out material) which is the standard at many centres around the world and capilliary suction (where a tiny wire is drawn back slowly to create more gentle suction force) which is utilized often at LHSC.

The purpose of this study is to evaluate for differences in ROSE adequacy between these two methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age greater to or equal than 18 years old
  • Receiving an endobronchial ultrasound for any diagnostic reason

排除标准

  • Patients under 18 years old
  • Patient refuses consent to undergo endobronchial ultrasound or is incapable of decision making.

结局指标

主要结局

Procedure Duration

时间窗: During the procedure

Adequacy of ROSE sample (0-1)

时间窗: During the procedure

Number of ROSE preparations per patient

时间窗: During the procedure

次要结局

  • Adequate lymphocyte sampling (0-2)(During the procedure)
  • Adequate diagnostic cells (0-2)(During the procedure)
  • Amount of blood contamination on ROSE slide (0-2)(During the procedure)
  • Adequacy of final specimen for ancillary testing (1-3)(During the procedure)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (1)

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