Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

Study Overview
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Brief Summary
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Indonesia is one of country that contributes the most cases of tuberculosis worldwide. Tuberculosis is the most commonly etiology of exudative pleural effusion. There have been many studies about undiagnosed exudative pleural effusion, but there are not many studies about the use of medical thoracoscopy for diagnosing transudative and exudative pleural effusion, especially on biomarkers of C-Reactive Protein (CRP), D-dimer, Adenosine Deaminase (ADA), Antinuclear Antibody (ANA), C3 C4 complements, Cancer Antigen 125 (CA-125), Xpert Mycobacterium Tuberculosis (Xpert MTB), Lupus Erythematosus cell (LE cell), cytology (effusion and smear) and histopathology. Information gained from those biomarkers via thoracenthesis and medical troracoscopy, etiology of exudative and transudative pleural effusion can be detected earlier and clearly, especially etiology of infection, autoimmune, and malignancy that further can be used to reduce patients' hospitalization period, mortality, and to develop the new therapeutic agents.

Detailed Description
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Medical thoracoscopy is a minimally invasive procedure to access pleura with combination of visual and medical instrument. The procedure is performed under local anesthesia and conscious sedation. Medical thoracoscopy plays role in basic diagnotic and therapeutic. The most common indication on basic diagnostic is on pleural effusion case that has primary target to get specific diagnosis when the etiology of pleural effusion is unknown. Pleural effusion is fluid accumulation inside the pleura for about 15-20 ml. Primary aim of pleural effusion diagnosis is to differentiate exudative and transudative effusions based on Light Criteria. Most of time thoracentesis cannot give etiology of exudative and transudative pleural effusion. Researchers will evaluate subjects based on inclusion and exclusion criteria in Cipto Mangunkusumo Hospital. Furtehrmore, research subjects will be asked for informed consent. Data will be collected based on research form. Researcher will perform medical thoracoscopy to take specimen for analysing CRP, D-dimer, ADA, ANA, C3 C4 complements, Xpert MTB, LE cell, cytology (effusion and smear) and histopathology to detect the etiology of tuberculosis, malignancy or autoimmune.

Official Title
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Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

Conditions
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Medical Thoracoscopy

Intervention / Treatment
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* Procedure: Medical thoracoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized adult age 18 - 75 years old Willing to be involved in the research Undiagnosed transudative and exudative pleural effusion post-thoracentesis twice on right and left lung Patients can undergo medical thoracoscopy under local anesthesia, based on ATS and BTS guideline Exclusion Criteria: Pregnant and breastfeeding women Patients in non-invasive ventilation and mechanical ventilator Transudative and exudative pleural effusion with etiology of chronic heart failure, chronic kidney disease, hepatocirrhosis with or without hepatic hydrothorax and hypoalbuminemia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Hospitalized adults age 18 - 75 years old; Willing to be involved in the research; Undiagnosed transudative and exudative pleural effusion post-thoracentesis twice on right and left lung; Patients can undergo medical thoracoscopy under local anesthesia, based on ATS and BTS guideline.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: undiagnosed transudative and exudative pleural effusion<br>Subjects with undiagnosed transudative and exudative pleural effusion will undergo medical thoracoscopy as per studies protocols. | Procedure: Medical thoracoscopy<br>* Medical thoracoscopy is a minimally invasive procedure to have access to pleura with combination of visual and medical instrument. The procedure is done with local and light anesthesia. Medical thoracoscopy plays role in basic diagnosis and therapeutic. A Flex-rigid thoracoscope will be inserted through the trocar cannula in the rigt or left mid axillary line of the hemithorax<br>* Other names: Flex-rigid thoracoscope via trocar cannula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze role of medical thoracoscopy on undiagnosed transudative and exudative pleural effusion patients | To investigate whether medical thoracoscopy has a high diagnostic yield in undiagnosed transudative and exudative pleural effusion patients | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To know the prevalency of undiagnosed transudative and exudative pleural effusion. | Number of subjects with undiagnosed transudative and exudative pleural effusion will be assessed through medical thoracoscopy | Up to 12 months | 
| To know the etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion | Number of subjects with undiagnosed transudative and exudative pleural effusion will be classified for etiology of infection, autoimmune and malignancy at 2 weeks | 2 weeks | 
| To analyze biomarkers from blood (CRP, D-dimer, ANA, C3 C4 complements, CA-125) , , cytology (effusion and smear) and histopathology on undiagnoses transudative and exudative pleural effusion | Results of CRP, D-dimer, ANA, C3 C4 complements, CA-125 from blood samples from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months | Up to 12 months | 
| To analyze biomarkers from pleural effusion (ADA, Xpert MTB, LE cell) | Results of ADA, Xpert MTB, LE cell from pleural effusion samples from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months | Up to 12 months | 
| To analyze cytology (effusion and smear) and histopathology on undiagnosed transudative and exudative pleural effusion | Results of cytology and histopathology from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months | Up to 12 months |