Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159179
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-11-15
Brief Title:
Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion
Sponsor:
Dr Cipto Mangunkusumo General Hospital
Organization:
Dr Cipto Mangunkusumo General Hospital
Study Overview
Official Title:
Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None