Clinical trial NCT06159179: Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion
Official title: Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medical Thoracoscopy
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2023-12-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To analyze role of medical thoracoscopy on undiagnosed transudative and exudative pleural effusion patients
timeFrame: 2 weeks
Secondary outcomes:
measure: To know the prevalency of undiagnosed transudative and exudative pleural effusion.
timeFrame: Up to 12 months
measure: To know the etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion
timeFrame: 2 weeks
measure: 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
timeFrame: Up to 12 months
measure: To analyze biomarkers from pleural effusion (ADA, Xpert MTB, LE cell)
timeFrame: Up to 12 months
measure: To analyze cytology (effusion and smear) and histopathology on undiagnosed transudative and exudative pleural effusion
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Cipto Mangunkusumo Hospital
name: Gurmeet Singh, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.
citation: Rodriguez-Panadero F, Janssen JP, Astoul P. Thoracoscopy: general overview and place in the diagnosis and management of pleural effusion. Eur Respir J. 2006 Aug;28(2):409-22. doi: 10.1183/09031936.06.00013706. No abstract available.
citation: Ferreiro L, Toubes ME, San Jose ME, Suarez-Antelo J, Golpe A, Valdes L. Advances in pleural effusion diagnostics. Expert Rev Respir Med. 2020 Jan;14(1):51-66. doi: 10.1080/17476348.2020.1684266. Epub 2019 Nov 5.