Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions

Sponsor
Indonesia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05553665
Collaborator
Singapore General Hospital (Other)
124
1
2
10.9
11.3

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Medical thoracoscopy
  • Diagnostic Test: CRP, D-dimer, ADA, ANA, C3 C4 complements, CA-125, Xpert MTB, LE cell, cytology and histopathology
  • Drug: Lidocain, fentanyl and midazolam
N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: transudative pleural effusion

Subjects with undiagnosed transudative 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.
Other Names:
  • pleuroscopy
  • 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

    Other: exudative pleural effusion

    Subjects with undiagnosed 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.
    Other Names:
  • pleuroscopy
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Medical thoracoscopy diagnostic yield in undiagnosed transudative and exudative pleural effusion patients [2 weeks]

      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.

    Secondary Outcome Measures

    1. The incidence of undiagnosed transudative and exudative pleural effusion [2 weeks]

      The incidence measured by time in six months during subjects recruitment

    2. Number of Incidence with etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion [2 weeks]

      Incidence number of infection, autoimmune and malignancy measured by the result of medical thoracoscopy diagnostic yield

    3. Histopathology test result [2 weeks]

      Tissue taken from pleural cavity

    4. Pattern of C-Reactive Protein (CRP) [2 weeks]

      CRP (mg/L)

    5. Pattern of D-dimer [2 weeks]

      D-dimer (ng/ml)

    6. Pattern of Adenosine Deaminase (ADA) [2 weeks]

      ADA (U/L)

    7. Pattern of Anti Nuclear Antibody (ANA) [2 weeks]

      ANA (U)

    8. Pattern of C3 C4 complements [2 weeks]

      C3 C4 complements (mg/dL)

    9. Pattern of Carcinoma Antigen 125 (CA-125) [2 weeks]

      CA-125 (U/mL)

    10. Result of Xpert MTB [2 weeks]

      MTB not detected or MTB detected rifampicin sensitive or rifampicin resistance

    11. Pattern of Lupus Erythematosus cell (LE cell) [2 weeks]

      LE cell (%)

    12. Result of cytology test [2 weeks]

      Cytology taken from pleural effusion and brushing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Respirology and Critical Illness Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo General Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Indonesia University
    • Singapore General Hospital

    Investigators

    • Principal Investigator: Gurmeet Singh, Faculty of Medicine, Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. dr. Gurmeet Singh, SpPD-KP, FINASIM, Consultant of Respirology and Critical Illness, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05553665
    Other Study ID Numbers:
    • 1111/UN2.RST/HKP.05.00/2022
    First Posted:
    Sep 23, 2022
    Last Update Posted:
    Sep 23, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 23, 2022