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Comparison of two types of needles in bronchoscopy

Diagnostic yield of 22G-FNB needle vs the standard 22G needle during Endobronchial Ultrasound guided transbronchial needle aspiration (EBUS-TBNA) in undiagnosed mediastinal lymphadenopathy: A Pilot Randomized Controlled Trial (RCT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035589
Enrollment
100
Registered
2021-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J985- Diseases of mediastinum, not elsewhere classified Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 22G FNB needle: EBUS TBNA performed using the 22G FN Biopsy needle. Total duration: till the procedure completion Control Intervention1: 22 G EBUS TBNA needle: EBUS TBNA performed using

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. consecutive subjects planned for EBUS-TBNA 2. age greater than 18 years 3. Intrathoracic lymphadenopathy greater than 10 mm (short axis) on computed tomography (CT) of the chest

Exclusion criteria

Exclusion criteria: 1. Refusal of consent for the procedure 2. Any contraindications to Bronchoscopy or Endobronchial Ultrasound procedures 3. Pregnancy 4. Hypoxemia (SpO2 = 0.3) • Lung cancer staging

Design outcomes

Primary

MeasureTime frame
To compare the proportion of adequate aspirates between the two groups Timepoint: At 1 week

Secondary

MeasureTime frame
To compare the incidence of procedural complications between the two groupsTimepoint: At 1 week;To compare the proportion of diagnostic aspirates between the two groupsTimepoint: At 1 week;To compare the quality of cytopathological material obtained between the two groupsTimepoint: At 1 week

Countries

India

Contacts

Public ContactKaran Madan

AIIMS, New Delhi

drkaranmadan@gmail.com01126593488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026