Diagnostic Utility of EBUS-TBNA Versus Conventional TBNA With Rapid on Site Evaluation in the Diagnosis of Sarcoidosis: a Randomised Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
研究概览
简要总结
This trial compares the yield of cTBNA (conventional Transbronchial Needle Aspiration) versus the EBUS-TBNA (Endobronchial Ultrasound guided TBNA) for obtaining cytology when they are combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite examination (ROSE) of the obtained smears in the diagnosis of suspected sarcoidosis patients visiting our hospital for evaluation of mediastinal lymphadenopathy.
详细描述
This study is investigator initiated, prospective, unblinded randomized study comparing conventional TBNA with EBUS-TBNA for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis when combined with transbronchial lung biopsy and endobronchial biopsy. It will be conducted on 80 consecutive patients with suspected sarcoidosis presenting to Department of Pulmonary Medicine and Sleep Disorders in AIIMS (All India Institute of Medical Sciences), New Delhi. This study will help to know whether EBUS (Endobronchial Ultrasound guided) or conventional TBNA is better for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis. It will also help to know the value of adding rapid onsite evaluation of the cytology smears to both the procedures. It will also help to determine the overall yield of different procedures when they are combined for obtaining tissue samples for a diagnosis of sarcoidosis.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and suspected Stage 1 (mediastinal or hilar Lymphadenopathy (LAP)) or Stage 2 ( LAP and parenchymal abnormalities) sarcoidosis
- •Significant mediastinal LAP (Short Axis Diameter more than 10mm)
- •Lymph Node (LN) enlargement in station 4, 7, 10 or 11 and CT chest findings consistent with sarcoidosis.
- •With or without supportive evidence of sarcoidosis - hypercalcemia, calciuria, raised ACE levels or restriction/obstruction on Pulmonary Function Tests (PFT).
排除标准
- •Obvious other organ involvement with possibility to confirm granuloma with minimally invasive diagnostic procedure (Skin biopsy, superficial lymph nodes, Lofgren's Syndrome)
- •Sarcoidosis Stage 3 and 4
- •Mediastinal Nodes less than 10 mm in short axis diameter
- •Absence of right paratracheal and subcarinal Lymph node enlargement more than 1 cm in short axis diameter
- •Those who received empiric Steroid for >2 weeks in preceding 3 months
- •Contraindication to bronchoscopy and TBNA (Coagulopathy, Hypoxemia)
- •Unwilling to give consent
研究组 & 干预措施
cTBNA without ROSE
Patients who will undergo conventional TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
干预措施: cTBNA without ROSE (Other)
EBUS-TBNA with ROSE
Patients who will undergo EBUS-TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
干预措施: EBUS-TBNA with ROSE (Other)
cTBNA with ROSE
Patients who will undergo conventional TBNA with ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
干预措施: cTBNA with ROSE (Other)
EBUS-TBNA without ROSE
Patients who will undergo EBUS-TBNA without ROSE + Endobronchial biopsy + Transbronchial Lung Biopsy
干预措施: EBUS-TBNA without ROSE (Other)
结局指标
主要结局
Diagnostic Yield of Conventional TBNA vs EBUS TBNA with or without ROSE
时间窗: 6 months
Diagnostic Yield is defined as the number of patients with presence of non caseating granuloma on cytology smear divided by total number of sarcoidosis patient expressed as percentage
次要结局
- Negative predictive value of EBUS-TBNA when combined with ROSE in the diagnosis of Sarcoidosis(6 months)
- Negative predictive value of EBUS-TBNA in the diagnosis of Sarcoidosis(6 months)
- Yield of EBUS-TBNA in Conventional TBNA with or without ROSE negative patients(6 months)
- Specificity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Specificity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Positive predictive value of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Negative predictive value of conventional TBNA in the diagnosis of Sarcoidosis(6 months)
- Negative predictive value of conventional TBNA when combined with ROSE in the diagnosis of Sarcoidosis(6 months)
- Specificity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Specificity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Sensitivity of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Sensitivity of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Positive predictive value of conventional TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Positive predictive value of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Positive predictive value of conventional TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Sensitivity of EBUS-TBNA to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
- Sensitivity of EBUS-TBNA when combined with ROSE to detect Non Caseating Granuloma for the diagnosis of Sarcoidosis(6 months)
研究者
Dr. Ashesh Dhungana
Senior Resident, Department of Pulmonary Medicine and Sleep Disorders
All India Institute of Medical Sciences, New Delhi