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A clinical trial comparing the diagnostic yield of EBUS-TBNA using different number of needle passes through the mediastinal lymph nodes in patients having mediastinal lymphadenopathy.

Comparison of diagnostic yield of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) using different number of lymph node agitations in patients with mediastinal lymphadenopathy: A randomized pilot trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049627
Enrollment
120
Registered
2023-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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: Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) using 10-15 lymph node agitations in patients with mediastinal lymphadenopathy: We will perform EBUS-TBNA as

Sponsors

Randeep Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consenting subjects between 18 and 75 years of age. 2. Subjects with mediastinal lymphadenopathy scheduled for EBUS-TBNA as part of clinical care. 3. Enlarged ( >10 mm in short axis) intrathoracic lymph nodes seen on computed tomography (CT) /PET CT of the chest.

Exclusion criteria

Exclusion criteria: 1. Contra-indications to EBUS(coagulopathy, anticoagulation, thrombocytopenia, other bleeding diatheses). 2. Pregnant females.

Design outcomes

Primary

MeasureTime frame
To compare the diagnostic yield of EBUS-TBNA using different numbers of lymph node agitations (10-15 vs 15-20 vs 20-25) in patients with mediastinal lymphadenopathy.Timepoint: 8 week

Secondary

MeasureTime frame
1. To compare the diagnostic yield of EBUS-TBNA using 10-15 versus 15-20 versus 20-25 lymph node agitations in patients with malignant mediastinal lymph node involvement. 2. To estimate the rate of adverse events (bleeding, pneumothorax, hypoxemia, mediastinitis) in patients of mediastinal lymphadenopathy undergoing different number of agitations (10-15 vs 15-20 vs 20-25) per lymph node pass. 3. To compare the specimen adequacy using different numbers of agitations (10-15 vs 15-20 vs 20-25) for immunohistochemical/molecular analysis. Timepoint: 8 week

Countries

India

Contacts

Public ContactRandeep Singh

AIIMS Rishikesh

ruchi.pulm@aiimsrishikesh.edu.in7895973469

Outcome results

None listed

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