跳至主要内容
临床试验/NCT02906280
NCT02906280Unknown3 期

Randomized Controlled Trial Comparing the Performance of 19 Gauge Versus 22 Gauge EBUS-TBNA Needles in Lung Carcinoma

KU Leuven2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
3 期
发起方
KU Leuven
入组人数
78
试验地点
2
主要终点
Tissue core

研究概览

简要总结

EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.

详细描述

All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.

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

入选标准

  • (suspected) stage IV lung carcinoma identified on spiral computed tomography scan
  • requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis

排除标准

  • uncontrolled coagulopathy
  • tracheal stenosis

结局指标

主要结局

Tissue core

时间窗: 14 months

Descriptive tissue characteristics of tumor sample

次要结局

  • Tumor cellularity per area of diagnostic tissue(14 months)
  • Quantity of DNA extracted(14 months)
  • Success rate of Next Generation Sequencing(14 months)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christophe Dooms, MD, PhD

MD, PhD

KU Leuven

研究点 (2)

Loading locations...

相似试验