| CTRI Number |
CTRI/2024/11/076233 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which biopsy is better for diagnosing lung fluid build-up: cryo or forceps? |
|
Scientific Title of Study
|
Efficacy of semi-rigid thoracoscopic pleural cryo vs. forceps biopsy for evaluation of undiagnosed exudative pleural effusion. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amal V Raj |
| Designation |
Senior resident |
| Affiliation |
VMMC and SJH |
| Address |
Department of Pulmonary Medicine Critical care and Sleep Medicine VMMC and SJH New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7012136653 |
| Fax |
|
| Email |
vrajamal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Kumar |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Vardhman Mahavir Medical College & Safdarjung Hospital |
| Address |
Department of Pulmonary Medicine Critical care and Sleep Medicine
Vardhman Mahavir Medical College & Safdarjung Hospital,
Ansari Nagar,
New Delhi - 110029,
India.
New Delhi
DELHI
110029
India |
| Phone |
9911218081 |
| Fax |
|
| Email |
dr.rohitkumar@mail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amal V Raj |
| Designation |
Senior resident |
| Affiliation |
VMMC and SJH |
| Address |
Department of Pulmonary Medicine Critical care and Sleep Medicine VMMC and SJH New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7012136653 |
| Fax |
|
| Email |
vrajamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC & SAFDARJANG HOSPITAL
Ministry of Health & F.W., Govt. of India
NEW DELHI - 110 029
|
|
|
Primary Sponsor
|
| Name |
VMMC and SJH |
| Address |
VMMC and SJH
New Delhi
PIN 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Amal V Raj |
SAFDARJUNG HOSPITAL |
Room number 658,Department of Pulmonary medicine, Critical care and sleep medicine,Vardhman Mahavir Medical College & Safdarjung Hospital,
Ansari Nagar,
New Delhi
DELHI |
7012136653
vrajamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VMMC and SJH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J90||Pleural effusion, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Semirigid thoracoscopic cryo biopsy |
11 mm semirigid thoracoscopic cryo-probe
duration- one to three hours for the total procedure
|
| Comparator Agent |
Semirigid thoracoscopic forceps biopsy |
Conventional thoracoscopic biopsy forceps
duration- one to three hours for the total procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years
2.Presence of exudative pleural effusion
3.Absence of definitive diagnosis even after thoracocentesis and USG guided biopsy (if indicated)
|
|
| ExclusionCriteria |
| Details |
1. Unstable respiratory, cardiovascular, hemodynamic condition or uncorrected coagulation defects
2. Small pleural space or multiple adhesions visualized in ultrasound necessitating the use of rigid thoracoscopy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the diagnostic efficacy of semi-rigid thoracoscopic pleural cryobiopsy
versus forceps biopsy in cases of undiagnosed exudative pleural effusions |
baseline, 1-2 weeks post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the major and minor complications of semi-rigid thoracoscopic pleural biopsy.
2. To assess and compare semi rigid thoracoscopic pleural cryobiopsy and forceps biopsy in terms of
specimen size, procedure duration and ease of making histopathological diagnosis |
Immediate post procedure
1-2 weeks post procedure |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/11/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Demographic and historical data of eligible patients will be documented, including age, sex, radiological findings, and results of diagnostic thoracocentesis and ultrasound-guided biopsy if performed. Patients will also undergo semirigid thoracoscopy if standard thoracocentesis and ultrasound-guided biopsy are inconclusive. Pleural biopsies will be collected using a cryoprobe (19mm) and semirigid forceps biopsy, with eight biopsies taken using flexible forceps and four using a cryoprobe. The operator will assess the ease of biopsy acquisition using a visual analogue scale, documenting post-biopsy bleeding and procedure duration. Biopsies from each method will be tagged separately and sent for histopathological examination. The samples will be followed up in the Pathology department to evaluate biopsy size, crush artifacts, ease of diagnosis, and final diagnosis. |