Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

Not Applicable

Recruiting

• Conditions: Medical Thoracoscopy
• Interventions: Procedure: Medical thoracoscopy

• Registration Number: NCT06159179
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-04-15
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
undiagnosed transudative and exudative pleural effusion	Medical thoracoscopy	Subjects with undiagnosed transudative and exudative pleural effusion will undergo medical thoracoscopy as per studies protocols.

Primary Outcome Measures

Name	Time	Method
To analyze role of medical thoracoscopy on undiagnosed transudative and exudative pleural effusion patients	2 weeks	To investigate whether medical thoracoscopy has a high diagnostic yield in undiagnosed transudative and exudative pleural effusion patients

Secondary Outcome Measures

Name	Time	Method
To know the prevalency of undiagnosed transudative and exudative pleural effusion.	Up to 12 months	Number of subjects with undiagnosed transudative and exudative pleural effusion will be assessed through medical thoracoscopy
To analyze cytology (effusion and smear) and histopathology on undiagnosed transudative and exudative pleural effusion	Up to 12 months	Results of cytology and histopathology from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months
To know the etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion	2 weeks	Number of subjects with undiagnosed transudative and exudative pleural effusion will be classified for etiology of infection, autoimmune and malignancy at 2 weeks
To analyze biomarkers from pleural effusion (ADA, Xpert MTB, LE cell)	Up to 12 months	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
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	Up to 12 months	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

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia