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CTRI Number  CTRI/2023/06/053962 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 14/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Diagnostic utility of Medical Thoacoscopy among patients with undiagnosed pleural effusion 
Scientific Title of Study   To evaluate the diagnostic yield and safety of Medical Thoracoscopy in patients with Undiagnosed Exudative Pleural Effusion 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VIKAS Kumar 
Designation  DM Resident 
Affiliation  AIIMS Raipur 
Address  C 404, Jainam Planet
Near AIIMS Raipur, Tatibandh
Raipur
CHHATTISGARH
492099
India 
Phone  7011193408  
Fax    
Email  dr.vickyrocks@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR AJOY K BEHERA 
Designation  Additional professor 
Affiliation  AIIMS Raipur 
Address  Department of Pulmonary Medicine
AIIMS Raipur, Tatibandh
Raipur
CHHATTISGARH
492099
India 
Phone  8518881794  
Fax    
Email  drajoybeherakims@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR VIKAS Kumar 
Designation  DM Resident 
Affiliation  AIIMS Raipur 
Address  C 404, Jainam Planet
Near AIIMS Raipur, Tatibandh
Raipur
CHHATTISGARH
492099
India 
Phone  7011193408  
Fax    
Email  dr.vickyrocks@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
VIKAS KUMAR  AIIMS RAIPUR  Department of Pulmonary, Critical care and Sleep Medicine, D Block
Raipur
CHHATTISGARH 		 7011193408

dr.vickyrocks@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Raipur  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1. Age >18 years
2. Undiagnosed Exudative pleural effusion
3. Patients who will give consent
 
 
ExclusionCriteria 
Details  1. Pregnant females
2.Patients not willing to participate
3.Contraindications of thoracoscopy (lack of pleural space due to pleural thickening, previous pleurodesis; refractory cough, severe hypoxemia, unstable hemodynamic parameters, poor general health status, unable to lie down)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the diagnostic yield of medical thoracoscopy in patients with undiagnosed exudative pleural effusion
 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the safety profile of the medical thoracoscopy in the patients with undiagnosed exudative pleural effusion
2. To study the association between the clinical, demographic, radiological profile, thoracoscopic findings of the patients & the etiology of pleural effusion
 		 At Baseline 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/07/2023 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Pleural effusion is due to the pathological accumulation of fluid in the pleural space and is very common worldwide. Pleural fluid analysis to be sent to determine whether pleural fluid is transudative or exudative as per Lights criteria. Around 25 -40% patients can have undiagnosed pleural effusion after pleural fluid analysis accompanied with closed pleural biopsy. Closed pleural biopsy is relatively inferior in the diagnosis of malignant pleural diseases as compared to the medical thoracoscopy. As per literature search, there is no study in Central India regarding the efficacy of medical thoracoscopy in patients of undiagnosed exudative pleural effusion. Medical Thoracoscopic guided biopsy is superior to closed pleural biopsy for diagnosis of malignant pleural diseases. Pleural biopsy NAAT and MGIT is more sensitive for diagnosis of TB pleuritis as compared to pleural fluid NAAT and MGIT

 

Aims and Objectives –

1. To study the diagnostic yield of medical thoracoscopy in patients with undiagnosed exudative pleural effusion

2. To assess the safety profile of the medical thoracoscopy in the patients with undiagnosed exudative pleural effusion

3. To study the association between the clinical, demographic, radiological profile, thoracoscopic findings of the patients and the etiology of pleural effusion

 

•       Study design

The study will be a cross sectional descriptive study in the patients who remained undiagnosed exudative pleural effusion (after history, examination and pleural fluid analysis)  in the Department of Pulmonary Medicine.

•       Study setting

Site - The study will be conducted in the Department of Pulmonary Medicine in AIIMS Raipur Chhattisgarh.

Study population- The patients who remained as undiagnosed exudative pleural effusion will be enrolled for the study.

 

Sample Size – 75 (calculated based on studies)

 

Inclusion criteria

1. Age >18 years

2. Undiagnosed Exudative pleural effusion (after history, examination and pleural fluid analysis) (described in flow chart)

3. Patients who will give consent

Exclusion criteria

 1. Pregnant females

 2.Patients not willing to participate

 3.Contraindications of thoracoscopy (lack of pleural space due to pleural thickening, previous pleurodesis; refractory cough, severe hypoxemia, unstable hemodynamic parameters, deranged coagulation profile, poor general health status, unable to lie down)

Medical thoracoscopy procedure will be considered diagnostic if the pleural biopsy will show definitive features of diagnosis such as malignancy or granulomatous inflammation suggestive of TB or positive microbiological investigations

Statistical Analysis

The data will be collected regarding demographic profile, addiction history, co morbidities, pleural fluid analysis, radiological findings and thoracoscopy findings. The data will be entered as per information mentioned in Annexures. The data will be entered in Microsoft Excel sheet. After data collection, data will be cleaned before using Statistical Software (SPSS VERSION 28.0).Appropriate statistical tests will be used.

 

Ethical Issues

1.     Prior permission from the Institutional Ethical Committee to carry out the research

2.     Written consent of every patient will be taken.

 
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