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A study to compare the diagnostic accuracy of lung needle biopsy using endoscopic ultrasound with and without on-site microscopic evaluation by pulmonologist (P-ROSE) in patients with enlarged chest lymph nodes

TO COMPARE THE DIAGNOSTIC YIELD OF EBUS GUIDED TBNA WITH AND WITHOUT P-ROSE IN PATIENTS WITH MEDIASTINAL LESION

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091660
Enrollment
44
Registered
2025-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: P-ROSE: The specimen obtained by EBUS guided TBNA was gently pushed onto the clean glass slides by the central tube core needle and spread over the glass slides as evenly as possible.

Sponsors

NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients aged 18 years or more with undiagnosed Mediastinal lesions who consented to participate in the study

Exclusion criteria

Exclusion criteria: 1)Contra-indications of EBUS-TBNA 2) Patient unwilling to participate 3) Hemodynamic instability 4) Uncorrected coagulopathy 5) Recent myocardial infarction / unstable angina within 6 weeks

Design outcomes

Primary

MeasureTime frame
The diagnostic yield of EBUS guided TBNA with and without Rapid On-Site Evaluation by Pulmonologist (P-ROSE) in patients with mediastinal lesionsTimepoint: At the time of the procedure

Secondary

MeasureTime frame
Duration of procedure between both the groupsTimepoint: During Procedure;Dose of sedatives between both groupsTimepoint: During the procedure;Number of jabbing between the two groupsTimepoint: During the procedure;Number of passes between the two groupsTimepoint: During the procedure;Distribution of cases according to histo-cytopathological examination in the two groupsTimepoint: After the final reporting by the pathologist (Less than 7 days)

Countries

India

Contacts

Public ContactJ K SAINI

NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES

jk.saini@nitrd.nic.in9818012841

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026