Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions

Pleural Effusion Clinical Trial

Official title:

Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05553665
• Other study ID #: 1111/UN2.RST/HKP.05.00/2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2022
• Source: Indonesia University
• Contact: Gurmeet Singh, MD, PhD
• Phone: +6281385158159
• Email: gurmeetsingh10[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 effusions, 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 thoracocentesis and medical thoracoscopy, 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.

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 diagnostic 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. Research subjects will be asked for informed consent. Furthermore, data will be collected based on research form. Researchers 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

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.

Diagnostic Test:
• CRP, D-dimer, ADA, ANA, C3 C4 complements, CA-125, Xpert MTB, LE cell, cytology and histopathology
CRP, D-dimer, ADA, ANA, C3 C4 complements, CA-125, Xpert MTB, LE cell, cytology and histopathology taken from specimen of effusion and smear

Drug:
• Lidocain, fentanyl and midazolam
local anesthetic: lidocaine 2%, fentanyl 100 mg and midazolam 2 mg

Locations

Country	Name	City	State
Indonesia	Respirology and Critical Illness Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Singapore General Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

Ferreiro L, Toubes ME, San José ME, Suárez-Antelo J, Golpe A, Valdés 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. Review. — View Citation

Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical thoracoscopy diagnostic yield in undiagnosed transudative and exudative pleural effusion patients	Medical thoracoscopic diagnostic yield based on the diagnostic result of patients with undiagnosed transudative and exudative pleural effusion after maximum twice thoracocentesis with unknown etiology.	2 weeks
Secondary	The incidence of undiagnosed transudative and exudative pleural effusion	The incidence measured by time in six months during subjects recruitment	2 weeks
Secondary	Number of Incidence with etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion	Incidence number of infection, autoimmune and malignancy measured by the result of medical thoracoscopy diagnostic yield	2 weeks
Secondary	Histopathology test result	Tissue taken from pleural cavity	2 weeks
Secondary	Pattern of C-Reactive Protein (CRP)	CRP (mg/L)	2 weeks
Secondary	Pattern of D-dimer	D-dimer (ng/ml)	2 weeks
Secondary	Pattern of Adenosine Deaminase (ADA)	ADA (U/L)	2 weeks
Secondary	Pattern of Anti Nuclear Antibody (ANA)	ANA (U)	2 weeks
Secondary	Pattern of C3 C4 complements	C3 C4 complements (mg/dL)	2 weeks
Secondary	Pattern of Carcinoma Antigen 125 (CA-125)	CA-125 (U/mL)	2 weeks
Secondary	Result of Xpert MTB	MTB not detected or MTB detected rifampicin sensitive or rifampicin resistance	2 weeks
Secondary	Pattern of Lupus Erythematosus cell (LE cell)	LE cell (%)	2 weeks
Secondary	Result of cytology test	Cytology taken from pleural effusion and brushing	2 weeks