An interventional study of Medical thoracoscopy in Medical Thoracoscopy, sponsored by Dr Cipto Mangunkusumo General Hospital. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Dr Cipto Mangunkusumo General Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
Dr Cipto Mangunkusumo General Hospital is the lead sponsor of 39 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Subjects with undiagnosed transudative and exudative pleural effusion will undergo medical thoracoscopy as per studies protocols.
Procedure: Medical thoracoscopy
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
Also known as: Flex-rigid thoracoscope via trocar cannula
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
Time frame: 2 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 12 months
Started Nov 2022 (actual). Primary completion is estimated for Apr 2024, 17 months after the start.
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Dr Cipto Mangunkusumo General Hospital