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Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions

Primary Purpose

Pleural Effusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Medical thoracoscopy
CRP, D-dimer, ADA, ANA, C3 C4 complements, CA-125, Xpert MTB, LE cell, cytology and histopathology
Lidocain, fentanyl and midazolam
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Effusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Respirology and Critical Illness Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

transudative pleural effusion

exudative pleural effusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The incidence of undiagnosed transudative and exudative pleural effusion
The incidence measured by time in six months during subjects recruitment
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
Histopathology test result
Tissue taken from pleural cavity
Pattern of C-Reactive Protein (CRP)
CRP (mg/L)
Pattern of D-dimer
D-dimer (ng/ml)
Pattern of Adenosine Deaminase (ADA)
ADA (U/L)
Pattern of Anti Nuclear Antibody (ANA)
ANA (U)
Pattern of C3 C4 complements
C3 C4 complements (mg/dL)
Pattern of Carcinoma Antigen 125 (CA-125)
CA-125 (U/mL)
Result of Xpert MTB
MTB not detected or MTB detected rifampicin sensitive or rifampicin resistance
Pattern of Lupus Erythematosus cell (LE cell)
LE cell (%)
Result of cytology test
Cytology taken from pleural effusion and brushing

Full Information

First Posted
September 14, 2022
Last Updated
September 21, 2022
Sponsor
Indonesia University
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05553665
Brief Title
Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions
Official Title
Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transudative pleural effusion
Arm Type
Other
Arm Description
Subjects with undiagnosed transudative pleural effusion will undergo medical thoracoscopy as per studies protocols.
Arm Title
exudative pleural effusion
Arm Type
Other
Arm Description
Subjects with undiagnosed exudative pleural effusion will undergo medical thoracoscopy as per studies protocols.
Intervention Type
Procedure
Intervention Name(s)
Medical thoracoscopy
Other Intervention Name(s)
pleuroscopy
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CRP, D-dimer, ADA, ANA, C3 C4 complements, CA-125, Xpert MTB, LE cell, cytology and histopathology
Intervention Description
CRP, D-dimer, ADA, ANA, C3 C4 complements, CA-125, Xpert MTB, LE cell, cytology and histopathology taken from specimen of effusion and smear
Intervention Type
Drug
Intervention Name(s)
Lidocain, fentanyl and midazolam
Intervention Description
local anesthetic: lidocaine 2%, fentanyl 100 mg and midazolam 2 mg
Primary Outcome Measure Information:
Title
Medical thoracoscopy diagnostic yield in undiagnosed transudative and exudative pleural effusion patients
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The incidence of undiagnosed transudative and exudative pleural effusion
Description
The incidence measured by time in six months during subjects recruitment
Time Frame
2 weeks
Title
Number of Incidence with etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion
Description
Incidence number of infection, autoimmune and malignancy measured by the result of medical thoracoscopy diagnostic yield
Time Frame
2 weeks
Title
Histopathology test result
Description
Tissue taken from pleural cavity
Time Frame
2 weeks
Title
Pattern of C-Reactive Protein (CRP)
Description
CRP (mg/L)
Time Frame
2 weeks
Title
Pattern of D-dimer
Description
D-dimer (ng/ml)
Time Frame
2 weeks
Title
Pattern of Adenosine Deaminase (ADA)
Description
ADA (U/L)
Time Frame
2 weeks
Title
Pattern of Anti Nuclear Antibody (ANA)
Description
ANA (U)
Time Frame
2 weeks
Title
Pattern of C3 C4 complements
Description
C3 C4 complements (mg/dL)
Time Frame
2 weeks
Title
Pattern of Carcinoma Antigen 125 (CA-125)
Description
CA-125 (U/mL)
Time Frame
2 weeks
Title
Result of Xpert MTB
Description
MTB not detected or MTB detected rifampicin sensitive or rifampicin resistance
Time Frame
2 weeks
Title
Pattern of Lupus Erythematosus cell (LE cell)
Description
LE cell (%)
Time Frame
2 weeks
Title
Result of cytology test
Description
Cytology taken from pleural effusion and brushing
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gurmeet Singh, MD, PhD
Phone
+6281385158159
Email
gurmeetsingh10@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Laila Fakhriyatuz Zakiyah, MBBS
Phone
+6282139248828
Email
lailafz2007@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurmeet Singh
Organizational Affiliation
Faculty of Medicine, Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respirology and Critical Illness Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
12075059
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.
Results Reference
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PubMed Identifier
16880371
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.
Results Reference
background
PubMed Identifier
31640432
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.
Results Reference
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Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusions

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