| CTRI Number |
CTRI/2025/11/097017 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
Utility of Balloon Application during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized controlled trial (RCT) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karan Madan |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
New Private Ward, 3rd floor, Pulmonary Medicine Ward, AIIMS New Delhi, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968859630 |
| Fax |
|
| Email |
drkaranmadan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yash Jain |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
New Private Ward, 3rd floor, Pulmonary Medicine Ward, AIIMS New Delhi, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8359817871 |
| Fax |
|
| Email |
yjainon5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yash Jain |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
New Private Ward, 3rd floor, Pulmonary Medicine Ward, AIIMS New Delhi, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8359817871 |
| Fax |
|
| Email |
yjainon5@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi, Ansari Nagar, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Karan Madan |
| Address |
New Private Ward, 3rd floor, Pulmonary Medicine Department, AIIMS New Delhi, Ansari Nagar, New Delhi, INDIA, pin Code: 110029 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Karan Madan |
AIIMS Delhi |
Room-Bronchoscopy Suite, Department of Pulmonary, Critical Care and Sleep Medicine
New Delhi
DELHI |
9968859630
drkaranmadan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J985||Diseases of mediastinum, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balloon Inflation during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) procedure. |
Balloon inflation will be done in allocated group while performing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) procedure from mediastinal lymph nodes. Will be done in each enrolled case for EBUS TBNA for total 2 years of study duration. |
| Comparator Agent |
Not inflating the Balloon during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) procedure |
Balloon inflation will be Not done in allocated group while performing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) procedure from mediastinal lymph nodes. Will be done in each enrolled case for EBUS TBNA for total 2 years of study duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing EBUS TBNA from mediastinal Lymphnodes |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
At baseline only.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in Sample Adequacy between the intervention & the control arm. Based on Pathology or Microbiology report.
|
At baseline |
To determine procedure related satisfaction between the intervention & the control arm using VAS (0-100) scale.
|
At Baseline
|
| Difference in the Complications rate of the procedure between the intervention & the control arm (Bleeding/Hypoxemia/Pneumothorax) |
At Baseline. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel
group, single center with study setting being bronchoscopy suite, Department of
pulmonary medicine, AIIMS Delhi. Trial will compare ultrasound image quality on
VAS 0-100 scale along with successful needle aspiration between groups with
balloon inflation during EBUS TBNA procedure and no balloon inflation during
procedure. Trial will run for a period of 2 years with expected sample size of
around 140 participants. Primary outcomes of study will be to determine the
difference in Ultrasound Image Quality during EBUS, between the intervention
and the control arm using VAS 1-100 scale and Proportion of subjects undergoing
successful needle aspiration i.e. three adequate passes from the intended lymph
node station/stations, between the groups. Secondary outcomes will be difference
in Sample Adequacy between the intervention and the control arm. To compare the
Overall operator rated procedure satisfaction between the intervention and the
control arms using VAS 0-100 scale and lastly difference in the Complications
rate of the procedure between the intervention and the control arm. Study will
help to study clinical impact of balloon inflation on image quality and
procedural outcomes during EBUS TBNA procedure. |