FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061428 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 02/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Role of Medical Thoracoscopy to find out the cause of fluid that accumulates in the pleural space 
Scientific Title of Study   Role of Medical Thoracoscopy in the evaluation of 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  Anjana Ledwani 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9731558864  
Fax    
Email  anjana.ledwani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sameer Adwani 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9503438992  
Fax    
Email  adwanisameer@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjana Ledwani 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education, Sawangi Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9731558864  
Fax    
Email  anjana.ledwani@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha 
 
Primary Sponsor  
Name  Datta Meghe Institute of higher education and research 
Address  Sawangi Meghe, Wardha 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anjana Ledwani  Acharya Vinoba Bhave Rural Hospital  Ward no. 37, Department of Respiratory Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe
Wardha
MAHARASHTRA 
9731558864

anjana.ledwani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Medical Sciences  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 
Intervention  Medical Thoracoscopy  Patients with Undiagnosed pleural effusion will undergo thoracoscopy in which pleural biopsy will be taken from the lesion and sent for histopathological examination for diagnosis. Thoracoscopy will require a pre procedure complete evaluation which will take 2 days, the procedure will take 1 day and histopathological examination of pleural biopsy will take around 4-7 days. So a total of 10-14 days will be required for the intervention.  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult (18 years and above) patients with pleural effusion admitted to the Department of Respiratory Medicine at AVBRH 
 
ExclusionCriteria 
Details  1.Patient unfit for undergoing thoracoscopy
2.Patients that deny consent to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The role of thoracoscopy in patients with diagnosed and undiagnosed effusion will be assessed
2. The efficacy of medical thoracoscopy in the diagnosis of pleural effusion will be studied
3. Correlation will be determined between findings of medical thoracoscopy with biochemical and cytological parameters of pleural fluid.
 
2-4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
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 3/ Phase 4 
Date of First Enrollment (India)   12/01/2024 
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="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  

Pleural effusion is the pathological accumulation of fluid in the pleural space surrounding the lungs and is associated with a wide variety of diseases such as bacterial pneumonia, congestive heart disease, and malignancies. Undiagnosed pleural effusion is defined as the inability to make an accurate etiologic diagnosis following an initial microscopic and biochemical examination of the pleural fluid. Medical thoracoscopy (MT) is an essential diagnostic and therapeutic procedure for multiple pleural conditions such as pleurisy, pleural effusion, and pneumothorax. It is typically carried out when multiple thoracocentesis have failed to identify the cause of the pleural effusion. The diagnostic yield is maximized by medical thoracoscopy (MT)/pleuroscopy, which enables pleural biopsy under direct view utilizing several accessible (rigid or flexi-rigid) equipment. This research aims to study the role of medical thoracoscopy in the evaluation of pleural effusion.

This hospital-based prospective and interventional study will span from July 2022 to July 2024, enrolling 50 adult patients aged 18 years and older admitted to the Department of Respiratory Medicine, a tertiary care hospital in central India. Data will be collected using a structured proforma, encompassing demographic data, clinical history, and comorbidities. Diagnostic investigations, including pleural fluid analysis, sputum analysis, and radiological assessments, will be performed upon enrolment. The patients having undiagnosed pleural effusion will undergo a medical thoracoscopy after taking informed consent. The purpose of the study is to describe the diagnostic efficacy of thoracoscopy and to correlate its findings to pleural fluid parameters. 

 
Close