Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound Guided Biopsy When Using a Thick (1.7mm) With an Aspiration Needle Biopsy Vs. a Thin USS Probe (1.4mm), in Peripheral Lung Lesions.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Comparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath.
研究概览
简要总结
Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous origin is of utmost importance. Due to it's markedly favourable safety profile, a bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success rate), is sub-optimal.
There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be advanced more peripherally to obtain a biopsy.
Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield.
In this study, investigators compare these two types of probes in the ability to diagnose a PPL.
The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too small to accommodate an aspiration needle)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient referred for R-EBUS as per routine management.
- •Patient judged to be medically stable to give consent for this study.
排除标准
- •Unsuitable for flexible bronchoscopy and biopsy
- •Platelets<
- •Hb> 80g/l
- •Liver function tests (AST/ALT) <2 times upper limit of normal
- •Neutrophil count >1.0
- •EGFR >30ml/kg/min
- •On anticoagulation, that cannot be withheld for the procedure, due to medical reasons (e.g. On-clopidogrel with recent drug-eluting stent placement.)
研究组 & 干预措施
Thick USS (1.7mm) with use of additional aspiration needle
干预措施: Radial EBUS biopsy (Procedure)
Thick USS (1.7mm) with use of additional aspiration needle
干预措施: Types of Radial Ultrasound probes (Device)
Thin USS (1.4mm)
干预措施: Radial EBUS biopsy (Procedure)
Thin USS (1.4mm)
干预措施: Types of Radial Ultrasound probes (Device)
结局指标
主要结局
Comparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath.
时间窗: 18 months
A blinded pathologist will assess all samples from the thick USS arm and all samples from the thin USS arm separately and come to a conclusion as 1. To what biopsies give a diagnosis of malignancy and 2. Will decide what is the best sample in comparing all samples from both arms defined as " the highest number of malignant cells/hpf".
次要结局
- Suitability of the biopsy samples from each arm to perform EGFR mutation testing.(18 months)
- Compare the procedure related bleeding and pneumothorax rates between the two arms.(18 months)
研究者
Samantha Herath
Respiratory Physician
Middlemore Hospital, New Zealand