Evaluating the Diagnostic Yield and Specimen Quality With Endobronchial Ultrasound-Guided Intranodal Forceps Biopsies in Patients With Mediastinal and Hilar Lymphadenopathy: A Prospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Diagnostic Yield
研究概览
简要总结
The investigators will compare endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) with intranodal forceps biopsy (EBUS-IFB) as it relates to the rate of diagnosis of suspected sarcoidosis.
详细描述
This is prospective, single center randomized comparative study to determine the diagnostic yield and specimen quality of endobronchial ultrasound guided intranodal forceps biopsy of patients with suspected sarcoidosis based solely on imaging. This will be a single group study and will compare transbronchial needle aspiration via 19 or 21-gauge needle with intranodal forceps biopsy.
The study aims to answer a knowledge gap a as to whether the diagnostic yield and specimen quality of EBUS-TBNA with a 19G needle is less than those obtained by 1.9mm or greater intranodal forceps biopsy. The study proposed here will add to the field by further elucidating whether this procedure is beneficial for the diagnosis as it pertains to suspected sarcoidosis.
The anticipated required enrollment is 55 patients to achieve an α of 0.05 and β of 0.2. This assumes an unassisted diagnostic yield of 62.5% with standard of care EBUS-TBNA as reported in Ray et al, and a diagnostic supplementation to 80% yield with intranodal forceps biopsies.
References
- Oki, M., Saka, H., & Sako, C. (2004). Bronchoscopic miniforceps biopsy for mediastinal nodes. Journal of Bronchology & Interventional Pulmonology, 11(3), 150-153.
- Herth FJ, Morgan RK, Eberhardt R, Ernst A. Endobronchial ultrasound-guided miniforceps biopsy in the biopsy of subcarinal masses in patients with low likelihood of non-small cell lung cancer. Ann Thorac Surg. 2008 Jun; 85(6):1874-8.
- Chrissian A, Misselhorn D, Chen A. Endobronchial-ultrasound guided miniforceps biopsy of mediastinal and hilar lesions. The Annals of Thoracic Surgery. 2011;92(1):284-288.
- Franke KJ, Bruckner C, Szyrach M, Ruhle KH, Nilius G, Theegarten D. The contribution of endobronchial ultrasound-guided forceps biopsy in the diagnostic workup of unexplained mediastinal and hilar lymphadenopathy. Lung. 2012;190(2):227-232.
- Herth FJF, Schuler H, Gompelmann D, et al. Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study. European Respiratory Journal. 2012;39(2):373-377.
- Darwiche K, Freitag L, Nair A, et al. Evaluation of a novel endobronchial ultrasound-guided lymph node forceps in enlarged mediastinal lymph nodes. Respiration. 2013;86(3):229-236.
- Ray AS, Li C, Murphy TE, et al. Improved diagnostic yield and specimen quality with endobronchial ultrasound-guided forceps biopsies: a retrospective analysis. The Annals of Thoracic Surgery. 2020;109(3):894-901
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)
盲法说明
The participant will be blinded to which group they were randomized to.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologic evidence of mediastinal and/or hilar lymphadenopathy
- •Attending radiologist or pulmonologist reports a possible diagnosis of sarcoidosis
- •Age 18 years or older
排除标准
- •These are the characteristics that a participant must NOT have in order to be eligible to participate in the study.
- •Order Number Criteria
- •Severe pulmonary hypertension
- •Inability to undergo general anesthesia
- •Severe coagulopathy or bleeding diathesis
- •Previously diagnosed sarcoidosis
- •Patient presently taking clopidogrel
- •Patient deemed to be high risk for general anesthesia per anesthesiologist
- •Hemodynamic instability
- •Mediastinitis
- •Acute Hypercarbic Respiratory Failure (pCO2 >55mmHg)
研究组 & 干预措施
EBUS-TBNA
These will be the patient who undergo EBUS-TBNA only without EBUS-IFB
干预措施: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy (Procedure)
EBUS-TBNA + EBUS-IFB
These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure
干预措施: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy (Procedure)
结局指标
主要结局
Diagnostic Yield
时间窗: 1 year
Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone
次要结局
- Duration of Procedure(1 year)
- Complications(1 year)
研究者
Khalil Diab
MD - Associate Professor
George Washington University