Diagnostic utility of Medical Thoacoscopy among patients with undiagnosed pleural effusion

Not yet recruiting

Conditions: Pleural effusion, not elsewhere classified,

Registration Number: CTRI/2023/06/053962

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** â€“

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

â€¢ **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.

â€¢ **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 â€“** 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.**

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

Age >18 years 2.
Undiagnosed Exudative pleural effusion 3.
Patients who will give consent.

Exclusion Criteria

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).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To study the diagnostic yield of medical thoracoscopy in patients with undiagnosed exudative pleural effusion	At baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): AIIMS RAIPUR
🇮🇳
Raipur, CHHATTISGARH, India
AIIMS RAIPUR
🇮🇳Raipur, CHHATTISGARH, India
VIKAS KUMAR
Principal investigator
7011193408
dr.vickyrocks@gmail.com