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Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

NCT ID: NCT06159179

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-05-15

Brief Summary

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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

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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.

Conditions

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Medical Thoracoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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undiagnosed transudative and exudative pleural effusion

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

Group Type OTHER

Medical thoracoscopy

Intervention Type 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

Interventions

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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. A Flex-rigid thoracoscope will be inserted through the trocar cannula in the rigt or left mid axillary line of the hemithorax

Intervention Type PROCEDURE

Other Intervention Names

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Flex-rigid thoracoscope via trocar cannula

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role collaborator

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gurmeet Singh, MD

Head Division Respirology and Critical Illness, Internal Medicine Department, Principal Investigator, Respirology and Critical Illness Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gurmeet Singh, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Dr Cipto Mangunkusumo General Hospital

Locations

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Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Gurmeet Singh, MD, PhD

Role: CONTACT

Phone: +6281385158159

Email: [email protected]

Facility Contacts

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Gurmeet Singh, MD, PhD

Role: primary

Rizki Triono, MD

Role: backup

References

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

Reference Type BACKGROUND
PMID: 12075059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16880371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31640432 (View on PubMed)

Other Identifiers

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1111/UN2.RST/HKP.05.00/2022

Identifier Type: -

Identifier Source: org_study_id

NCT05553665

Identifier Type: -

Identifier Source: nct_alias