| CTRI Number |
CTRI/2025/02/079943 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine the Safety and Efficacy of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy. |
|
Scientific Title of Study
|
Safety and Efficacy of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy in the diagnosis of Mediastinal lesions :A Prospective Study |
| 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 Kuruva Sai Anudeep |
| Designation |
Senior Resident |
| Affiliation |
Aiims Jodhpur |
| Address |
Room no 36,Dept of Pulmonary Medicine,opd block,Ground floor,Aiims Hospital ,Basni,Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9182307694 |
| Fax |
|
| Email |
ksaianudeep95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Kumar Chauhan |
| Designation |
Professor |
| Affiliation |
Aiims Jodhpur |
| Address |
ROOM NO 34,Dept of Pulmonary Medicine,Opd block,zround floor,Aiims Hospital,Basni,Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996884 |
| Fax |
|
| Email |
nishant97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NISHANT KUMAR CHAUHAN |
| Designation |
PROFESSOR |
| Affiliation |
Aiims Jodhpur |
| Address |
ROOM NO 39,Dept of Pulmonary Medicine,Opd block,Groud floor,Aiims Hospital,Basni,Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996884 |
| Fax |
|
| Email |
nishant97@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical scines,Basni,Jodhpur,Rajasthan,342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Room no 38,Department of Pulmonary Medicine,OPD Block,Ground Floor,Aiims Hospital,Basni,Jodhpur,Rajasthan,342005 |
| 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 Kuruva Sai Anudeep |
AIIMS JODHPUR |
Room no 36,Ground floor,Opd block,Aiims Hospital,Basni,Jodhpur,Rajaasthan,342005
Jodhpur
RAJASTHAN |
9182307694
ksaianudeep95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE,AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy(EBUS-MCB) |
All patients with undiagnosed mediastinal lesions will undergo EBUS TBNA and EBUS-MCB in the sample lymph node in the same setting
|
| Comparator Agent |
Endobronchial Ultrasound-Guided Needle Aspiration cytology(EBUS-TBNA) |
EBUS TBNA is the gold standard for diagnosis of mediastinal lesions.
All patients with undiagnosed mediastinal lesions will undergo EBUS TBNA and EBUS-MCB in the sample lymph node in the same setting.
Comparision is done between pathological diagnosis of EBUS-TBNA and EBUS-MCB. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Greater than 18 years
2.Patients with undiagnosed mediastinal lesions greater than 1 cm requiring pathology examination for diagnosis |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years
2.Highly Vascular,necrotic lymph nodes and unhealthy mucosa at the site of biopsy
3.uncorrectable severe coagulation abnormalities
4.Refractory hypoxemia(sp02 less than 90% with fio2 more than 60)
5.Unstable cardiac arrhythmias,Severe Pulmonary Hypertension(RVSP greater than 50mmHg)
6.Recent MI (less than 4 weeks) or ongoing unstable angina
7.Benign/malignant stenosis of upper airway |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and efficacy of Endobronchial Ultrasound-Guided Cryobiopsy in the Mediastinal lesions.Safety is determined by complications and efficacy is determined by positive biopsy results |
Safety at time of study(baseline) and till 2 weeks
Efficacy at the time of study (baseline)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Yield of Endobronchial Ultrasound-Guided Mediastinal Cryobiopsy vs Endobronchial Ultrasound-guided Fine needle Aspiration
|
Yield is determined by percentage of patients with positive biopsy results (After the study period)
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/02/2025 |
| 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="6"
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
|
After CTRI Approval our study will enroll patients presenting to Pulmonary Medicine Department with undiagnosed mediastinal lymphadenopathy who requires definite diagnosis with pathological examination based on inclusion and exclusion criteria Aim To determine the safety and efficacy of the Endobronchial ultrasound-Guided Mediastinal cryobiopsy (EBUS-MCB) in mediastinal lesions (>1cm) Primary Objective 1. To determine procedural safety of EBUS-MCB by rate of procedure-related complications like pneumothorax, bleeding, mediastinitis and pneumomediastinum 2. Efficacy will be determined by percentage of patients for whom mediastinal biopsy provides a definite diagnosis Secondary Objective To compare the diagnostic yield of EBUS-TBNA and EBUS-MCB in mediastinal lesions(>1cm) Summary .The procedure will be carried out under general Anaesthesia using the laryngeal mask airway/I gel/ET Tube .After this airways will be visualised and Endobronchial Ultrasound-guided Transbronchial Aspiration will be done. After this through the same track created, Cryobiopsy probe will be introduced and Endobronchial Ultrasound guided Mediastinal Cryobiopsy(EBUS-MCB) will be done .At least 3 cryobiopsy specimens will be obtained. Complications if any will be noted during the procedure .A post procedure chest radiograph will be obtained in all cases.All the samples collected will be sent for pathological examination. Patients will be followed up after 24 hrs and till 2 weeks(on call) to see if any delayed complications.Pathogical report will be collected and diagnosis will be done based on the report. |