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Study comparing use of a balloon versus no balloon during EBUS-TBNA, a lung needle test, to see if it improves ultrasound image quality and sample yield in patients with chest lymph-node swelling.

Utility of Balloon Application during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized controlled trial (RCT) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097017
Enrollment
140
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Interventions

Intervention1: Balloon Inflation during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) procedure.: Balloon inflation will be done in allocated group while performing Endo

Sponsors

Dr Karan Madan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing EBUS TBNA from mediastinal Lymphnodes

Exclusion criteria

Exclusion criteria: 1. Lack of consent 2. Staging EBUS TBNA for Carcinoma lung 3. Procedure Performed under General Anesthesia 4. Uncorrectable Coagulopathy 5. Refractory Hypoxemia 6. Unstable cardiac arrhythmias

Design outcomes

Primary

MeasureTime frame
1. Determine the difference in Ultrasound Image Quality during EBUS, between the intervention and the control arm [VAS (0-100) scale]. 2. Proportion of subjects undergoing successful needle aspiration (i.e. three adequate passes from the intended lymph node station/stations), between the groups. Timepoint: At baseline only.—

Secondary

MeasureTime frame
Difference in Sample Adequacy between the intervention & the control arm. Based on Pathology or Microbiology report. Timepoint: At baseline;To determine procedure related satisfaction between the intervention & the control arm using VAS (0-100) scale. Timepoint: At Baseline ;Difference in the Complications rate of the procedure between the intervention & the control arm (Bleeding/Hypoxemia/Pneumothorax)Timepoint: At Baseline.—

Countries

India

Contacts

Public ContactDr Yash Jain

AIIMS New Delhi

yjainon5@gmail.com8359817871

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026