| 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
|
|
|
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
|
|
|
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. |