| CTRI Number |
CTRI/2025/07/091660 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
TO COMPARE THE DIAGNOSTIC YIELD OF EBUS GUIDED TBNA WITH AND WITHOUT P-ROSE IN PATIENTS WITH MEDIASTINAL LESION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J K SAINI |
| Designation |
CHEST SPECIALIST (SAG) |
| Affiliation |
NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES |
| Address |
ROOM NO 4 ,RESEARCH BLOCK,NITRD, SRI AUROBINDO MARG,NEW DELHI
South
DELHI
110030
India |
| Phone |
9818012841 |
| Fax |
|
| Email |
jk.saini@nitrd.nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
J K SAINI |
| Designation |
CHEST SPECIALIST (SAG) |
| Affiliation |
NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES |
| Address |
ROOM NO 4,RESEARCH BLOCK, NITRD, SRI AUROBINDO MARG, NEW DELHI
South
DELHI
110030
India |
| Phone |
9818012841 |
| Fax |
|
| Email |
jk.saini@nitrd.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
J K SAINI |
| Designation |
CHEST SPECIALIST (SAG) |
| Affiliation |
NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES |
| Address |
ROOM NO 4, RESEARCH BLOCK, NITRD, SRI AUROBINDO MARG, NEW DELHI
South
DELHI
110030
India |
| Phone |
9818012841 |
| Fax |
|
| Email |
jk.saini@nitrd.nic.in |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES |
| Address |
ROOM NO 4,RESEARCH BLOCK,NITRD, SRI SUROBINDO MARG,NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GOKUL VIKNESH C |
National Institute of Tuberculosis and Respiratory Diseases |
ROOM NO 4
RESEARCH BLOCK
NITRD
SRI AUROBINDO MARG
NEW DELHI
South
DELHI |
9597789642
bcgvpilot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NATIONAL INSTITUTE OF TUBERCULOSIS AND RESPIRATORY DISEASES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NON P-ROSE |
All NON-P-ROSE group specimens will be fixed with 95% alcohol for cytological examination by the pathologist . The pathologist examining the slides is blinded to whether P-ROSE was performed or not. All the parameters will then be compared with the P-ROSE group.
Final cytopathological diagnosis will be available within 7 days
|
| Intervention |
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. The specimens in P-ROSE and non-P-ROSE groups will be treated differently.
One of the slides in the P-ROSE group will be taken randomly and stained by a trained pulmonologist using Diff-quick cell staining solution to observe the adequacy of cellularity under the microscope, who then decides whether sampling was completed successfully, or should be re-performed.The other slides will be placed in a bottle containing 95% alcohol for subsequent cytological examination by the cytopathologist.
Within 3 minutes the pulmonologist examining the slides will say sampling is adequate or not.
If adequate cells were not detected by P-ROSE, further sampling of the lymph nodes will be done.If adequate cells were detected by P-ROSE then further sampling of the lymph node will be avoided. A maximum of four passes was standardized in the non P-ROSE group.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 18 years or more with undiagnosed Mediastinal lesions who consented to participate in the study |
|
| ExclusionCriteria |
| Details |
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
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The diagnostic yield of EBUS guided TBNA with and without Rapid On-Site Evaluation by Pulmonologist (P-ROSE) in patients with mediastinal lesions |
At the time of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of procedure between both the groups |
During Procedure |
| Dose of sedatives between both groups |
During the procedure |
| Number of jabbing between the two groups |
During the procedure |
| Number of passes between the two groups |
During the procedure |
| Distribution of cases according to histo-cytopathological examination in the two groups |
After the final reporting by the pathologist (Less than 7 days) |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - De identified individual participant data including demographic details , diagnostic yield, sample adequacy and histo-cytopathological outcomes related to with and without P-ROSE
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bcgvpilot@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 01-01-2029?
Response (Others) - 6 MONTHS AFTER PUBLICATION OF THE PRIMARY RESULTS AND WILL REMAIN AVAILABLE FOR 3 YEARS
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective randomised study conducted at a tertiary care center in New Delhi to assess the role of Rapid On-Site Evaluation by Pulmonologist (P-ROSE) during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) in patients with mediastinal lymphadenopathy. The study aims to compare the diagnostic yield between procedures performed with and without P-ROSE. Patients undergoing EBUS-TBNA for evaluation of mediastinal lesions will be divided into two groups: one with P-ROSE and the other without P-ROSE. Cytopathological outcomes will be analyzed to determine the impact of P-ROSE on real-time adequacy assessment and diagnostic accuracy. This study is expected to provide insights into the utility of P-ROSE in improving procedural efficiency and sample quality during EBUS. |