EBUS-TBNA vs EUS-B-FNA for Needle Aspiration of Mediastinal Lesions

Objectives

Primary objective:

Comparison of Proportion of Adequate and Diagnostic Aspirates in the EUS-B-FNA versus EBUS-TBNA arms as the primary approach for mediastinal fine needle aspiration during Convex probe EBUS.

Secondary objectives

• Topical Anaesthetic requirement between the two groups
• Intravenous Sedative / analgesic requirement between the two groups
• Operator rated overall procedure satisfaction (VAS)
• Operator rated cough (VAS)
• Overall duration of procedure Methods Study Design: Prospective randomised study. Sample Size: Number of Patients: 100 (50 -EBUS-TBNA arm, 50- EUS-B-FNA arm)

Inclusion criteria

• Age 18 years and Older
• Patients with predominant Subcarinal or Lower Left paratracheal located mediastinal lymphadenopathy/mediastinal lesions at least >1cm in Short axis diameter.
• Patients who give consent.

Exclusion criteria

• Refusal of consent for the procedure
• Any contraindications to Bronchoscopy or Endobronchial Ultrasound procedures
• Pregnancy Controls: None For all patients, a targeted history will be obtained to screen for diabetes mellitus, systemic hypertension, bleeding disorders, cardiac disease, previous anaesthetic complications and any medication history including antiplatelet therapy. Baseline investigations like complete hemogram and prothrombin time will be done, and imaging prior to the procedure will include a chest radiograph and computed tomography (CT) scan of the chest (plain and contrast enhanced).

The patients will then be randomised to 2 groups of 50 patients each. 50 patients in one group will undergo Transtracheal (EBUS-TBNA) approach, whereas in the other group, 50 patients will undergo Transesophageal (EUS-B-FNA) route as the primary approach using the EBUS scope. Procedures will be performed under moderate sedation. Procedures will be performed in the Bronchoscopy Lab.

The size and characteristics of the mediastinal lymph nodes as visualised during EBUS/EUS will be recorded. The concerned mediastinal lymph nodes will be sampled by EBUS-TBNA/EUS-FNA under direct ultrasonic visualisation. The aspirates will be expressed on to slides and will be placed into alcohol cytology bottles. The slides will then be dispatched to the Cytopathology Lab for appropriate stains and further analysis. Lymph node core if obtained will be sent in formalin for Histopathological analysis. Post procedure, the patients will remain in observation for a few hours and will be discharged on the same day. A patient proforma will be completed for each patient separately. The size and stations of the sampled nodes will be recorded. The total duration of procedure, the nature and total dose of anaesthesia or sedation will also be recorded. A Visual-analogue scale (VAS) will be used to assess operator rated procedure related cough and overall operator rated procedure satisfaction.

Statistical Analysis - Descriptive statistics such as mean, median, standard deviation and range will be calculated for all continuous variables. Frequency distributions will be calculated for all qualitative data. Frequency data across categorical variables will be compared using chi-square and fisher's exact test. Among patients with adequate sample on EBUS-TBNA/EUS-B-FNA, sensitivity, specificity, accuracy, and positive and negative predictive values will be calculated using standard formulas. P-value of P<0.05 is considered as statistically significant.

Inclusion criteria

• Age 18 years and Older
• Predominant Subcarinal or Lower Left paratracheal located mediastinal lymphadenopathy/mediastinal lesions at least >1cm in Short axis diameter.
• Patients who give consent

Exclusion criteria

• Refusal of consent for the procedure
• Any contraindications to Bronchoscopy / Endobronchial Ultrasound
• Pregnancy