Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

NCT06159179 | Unknown DMC

• 1 other identifier: 1111/UN2.RST/HKP.05.00/2022
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Thoracoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To know the prevalency of undiagnosed transudative and exudative pleural effusion.

  Up to 12 months

• To know the etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion

  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

  Up to 12 months

• To analyze biomarkers from pleural effusion (ADA, Xpert MTB, LE cell)

  Up to 12 months

• To analyze cytology (effusion and smear) and histopathology on undiagnosed transudative and exudative pleural effusion

  Up to 12 months

Study Arms (1)

undiagnosed transudative and exudative pleural effusion

OTHER

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

Procedure: Medical thoracoscopy

Interventions

Medical thoracoscopy PROCEDURE

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

undiagnosed transudative and exudative pleural effusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (3)

• Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.

  PMID: 12075059 BACKGROUND

• 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.

  PMID: 16880371 BACKGROUND

• 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.

  PMID: 31640432 BACKGROUND

Study Officials

• Gurmeet Singh, MD, Phd

  Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gurmeet Singh, MD, PhD

CONTACT

+6281385158159; gurmeetsingh10@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Division Respirology and Critical Illness, Internal Medicine Department, Principal Investigator, Respirology and Critical Illness Consultant

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 6, 2023
• Study Start: November 1, 2022
• Primary Completion: April 15, 2024
• Study Completion: May 15, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-11

Locations

ID (1)