| CTRI Number |
CTRI/2024/03/064920 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Thoracoscopic Cryobiopsy versus Forceps Biopsy in patients with undiagnosed exudative pleural effusuion |
|
Scientific Title of Study
|
A randomized trial to compare the diagnostic yield and patient safety profile of Thoracoscopic Flexible Forceps biopsy versus Thoracoscopic Cryo-biopsy in patients with 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 |
Dr J. K. Saini |
| Designation |
Head of Department of Thoracic oncology & Chest specialist (SAG) |
| Affiliation |
National Institute of TB and Respiratory diseases |
| Address |
Research Block Room number 4,Robert Koch research centre, National Institute of Tb and respiratory diseases Sri aurobindo marg new delhi 110030 Research Block Room number 4,Robert Koch research centre, National Institute of Tb and respiratory diseases Sri aurobindo marg new delhi 110030 New Delhi DELHI 110030 India |
| Phone |
919818012841 |
| Fax |
|
| Email |
jk.saini@nitrd.nic.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr J. K. Saini |
| Designation |
Head of Department of Thoracic oncology & Chest specialist (SAG) |
| Affiliation |
National Institute of TB and Respiratory Diseases |
| Address |
Research Block Room number 4,Robert Koch research centre, National Institute of Tb and respiratory diseases Sri aurobindo marg new delhi 110030 Research Block Room number 4,Robert Koch research centre, National Institute of Tb and respiratory diseases Sri aurobindo marg new delhi 110030 New Delhi DELHI 110030 India |
| Phone |
919818012841 |
| Fax |
|
| Email |
jk.saini@nitrd.nic.in |
|
Details of Contact Person Public Query
|
| Name |
Dr J.K. Saini |
| Designation |
Head of Department of Thoracic Oncology & Chest Specialisy (SAG) |
| Affiliation |
National Institute of TB and Respiratory Diseases |
| Address |
Research block room number 4, robert koch research centre, National Institute of Tb and respiratory diseases Sri aurobindo marg new delhi 110030 Research block room number 4, robert koch research centre, National Institute of Tb and respiratory diseases Sri aurobindo marg new delhi 110030 New Delhi DELHI 110030 India |
| Phone |
918595868390 |
| 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 TB and Respiratory diseases |
| Address |
NITRD, Sri Aurobindo Marg, New Delhi 110030 |
| 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 Shashank Shastry |
National Institute of TB and respiratory diseases |
Bronchoscopy Room, Department of respiratory medicine, opposite post operative block. New Delhi DELHI |
8595868390
shashankshastry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NITRD ethics committee |
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 |
| Comparator Agent |
Forceps Biopsy |
Pleural biopsy via thoracoscopy using flexible forceps (Estimated time 40 minutes) |
| Intervention |
Thoracoscopic cryo-pleural biopsy |
pleural biopsy during thoracoscopy using Erbe 2.4 mm Cryoprobe. (Estimated time 30 mins) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with undiagnosed exudative pleural effusion |
|
| ExclusionCriteria |
| Details |
1) Transudative effusion
2) empyema
3) haemodynamic instability |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic yield (whether or not diagnosis was made) |
5 days (duration of processing of histopathology report) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in post procedure pulse rate |
1 hour post procedure |
| change in post procedure blood pressure |
1 hour post procedure |
| comparison of tissue volume |
5 days (duration of processing of histopathology report) |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
10/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pleural effusion is the abnormal excessive accumulation of fluid in the pleural cavity. Pleural effusion per se is not a diagnosis but is indicative of an underlying pathology. It can occur by itself or can be the result of surrounding parenchymal diseases like infection, malignancy, or inflammatory conditions. Pleural effusion is one of the major causes of pulmonary mortality and morbidity. Patients with pleural effusions often present without many symptoms. Symptoms associated are pleuritic chest pain, cough, and shortness of breath. In addition, the patient will have symptoms related to the underlying cause. In India currently, the most common cause of pleural effusion is tuberculosis (59-65%) followed by malignancy (22-25%). Parapneumonic effusion and cardiac failure constitute about 20% of total cases. However, a small portion of cases of pleural effusion remained undiagnosed even after pleural fluid examination and cell block. Pleural biopsy via thoracoscopy is one of the most important methods of diagnosing pleural disorders. Forceps biopsies have been regularly used with semi-rigid thoracoscopy with good yield and safety. Cryo-pleural biopsy has been recently employed with semi-rigid thoracoscopy and many studies have been performed highlighting the safety and diagnostic yield. At present only 1 RCT has been performed comparing diagnostic yield of thoracoscopic cryo versus forceps biopsy.
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