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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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