Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Single-center, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Diagnostic yield of 22G-ProCore needle
研究概览
简要总结
The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.
详细描述
EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.
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
- 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
- •Imaging examination indicates enlarged intrathoracic lymph nodes need pathological diagnosis (any lymph node has a short diameter > 1 cm in CT or PET-CT SUV value > 2.5).
- •Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA.
- •Inform consent signed.
排除标准
- •Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count < 50000 or INR > 1.5).
- •Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.
- •Life expectancy less than 6 months.
- •Uncooperative patients.
- •Patients representing vulnerable populations (prisoners, pregnant women, etc).
- •Researchers consider it inappropriate to participate in this study.
研究组 & 干预措施
22G-ProCore Group
The experimental group with 22G-ProCore needle is expected to enroll 300 patients. The 22G-ProCore needle has a 1.5mm long groove 2.5mm above the needle tip, which is expected to have the advantage of taking more biopsy tissues than the 22G-Standard needle.
干预措施: 22G-ProCore Endobronchial Ultrasound Needle (Device)
22G-Standard Group
The control group of 22G-Standard needle is expected to include 300 patients, and there is no groove above the needle tip compared with 22G-ProCore needle.
干预措施: 22G-Standard Endobronchial Ultrasound Needle (Device)
结局指标
主要结局
Diagnostic yield of 22G-ProCore needle
时间窗: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Diagnostic yield of 22G-Standard needle
时间窗: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
次要结局
- The quality of histologic specimen used by 22G-ProCore needle(up to 6 months)
- The quality of histologic specimen used by 22G-Standard needle(up to 6 months)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy and Interventional Pulmonology, Shanghai Chest Hospital
Shanghai Chest Hospital