Medical ThoracoscopyNCT06159179
Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion
A study testing Medical thoracoscopy in people with Medical Thoracoscopy, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Medical Thoracoscopy
- What is being tested?
- Medical thoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2022to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Gurmeet Singh, MD, PhD, +6281385158159, gurmeetsingh10@yahoo.com
Rizki Triono, MD, +6281293329000, m.rizkitriono@gmail.com
About this study
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.
Read the 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.
- Conditions
- Medical Thoracoscopy
- Being tested
- Medical thoracoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical thoracoscopyProcedure or surgery
Also called Flex-rigid thoracoscope via trocar cannula
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
| Study group | Role | What they receive |
|---|---|---|
| undiagnosed transudative and exudative pleural effusion | Other | Subjects with undiagnosed transudative and exudative pleural effusion will undergo medical thoracoscopy as per studies protocols. Receives: Procedure: Medical thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (5)
To know the prevalency of undiagnosed transudative and exudative pleural effusion.
Number of subjects with undiagnosed transudative and exudative pleural effusion will be assessed through medical thoracoscopy
Measured: Up to 12 months
To know the etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion
Number of subjects with undiagnosed transudative and exudative pleural effusion will be classified for etiology of infection, autoimmune and malignancy at 2 weeks
Measured: 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
Results of CRP, D-dimer, ANA, C3 C4 complements, CA-125 from blood samples from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months
Measured: Up to 12 months
To analyze biomarkers from pleural effusion (ADA, Xpert MTB, LE cell)
Results of ADA, Xpert MTB, LE cell from pleural effusion samples from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months
Measured: Up to 12 months
To analyze cytology (effusion and smear) and histopathology on undiagnosed transudative and exudative pleural effusion
Results of cytology and histopathology from subjects with undiagnosed transudative and exudative pleural effusion will be known at 12 months
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Nov 2022
- Primary completion15 Apr 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medical ThoracoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Principal investigator, Gurmeet Singh, MD, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Gurmeet Singh, MD, Phd, Principal investigator, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159179
- Sponsor's protocol ID
- 1111/UN2.RST/HKP.05.00/2022
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.
PubMed 12075059Rodriguez-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.
PubMed 16880371Ferreiro 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.
PubMed 31640432Singh G, Rattu RBC, Rachmadi L, Rumende CM, Billianti YD, Wulandari D, Ali N, Sary SK, Magdalena B, Tahapary DL, Nata SCA, Harris A, Triono MR, Tay MCK. Sequential Pleural Fluid and Serum Biomarker Measurements in Patients Undergoing Medical Thoracoscopy for Persistently Undiagnosed Pleural Effusion: A Pilot Study from a TB-Endemic Tertiary Centre. Pulm Ther. 2026 Oct 23. doi: 10.1007/s41030-026-00388-5. Online ahead of print.
PubMed 42909836
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion
- ClinicalTrials.gov ID
- NCT06159179
- Acronym / sponsor ID
- 1111/UN2.RST/HKP.05.00/2022
- Conditions
- Medical Thoracoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| undiagnosed transudative and exudative pleural effusion | Other | Procedure: Medical thoracoscopySubjects with undiagnosed transudative and exudative pleural effusion will undergo medical thoracoscopy as per studies protocols. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical thoracoscopyAlso: Flex-rigid thoracoscope via trocar cannulaMedical 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 | Procedure or surgery | undiagnosed transudative and exudative pleural effusion |
Primary outcome
To analyze role of medical thoracoscopy on undiagnosed transudative and exudative pleural effusion patients
Time frame: 2 weeks
To investigate whether medical thoracoscopy has a high diagnostic yield in undiagnosed transudative and exudative pleural effusion patients
5 secondary outcomes
To know the prevalency of undiagnosed transudative and exudative pleural effusion.
Time frame: Up to 12 months
To know the etiology of infection, autoimmune and malignancy on undiagnosed transudative and exudative pleural effusion
Time frame: 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
Time frame: Up to 12 months
To analyze biomarkers from pleural effusion (ADA, Xpert MTB, LE cell)
Time frame: Up to 12 months
To analyze cytology (effusion and smear) and histopathology on undiagnosed transudative and exudative pleural effusion
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 12075059Light RW. Clinical practice. Pleural effusion. N Engl J Med. 2002 Jun 20;346(25):1971-7. doi: 10.1056/NEJMcp010731. No abstract available.
- Background: PubMed 16880371Rodriguez-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.
- Background: PubMed 31640432Ferreiro 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.
- Derived from this study: PubMed 42909836Singh G, Rattu RBC, Rachmadi L, Rumende CM, Billianti YD, Wulandari D, Ali N, Sary SK, Magdalena B, Tahapary DL, Nata SCA, Harris A, Triono MR, Tay MCK. Sequential Pleural Fluid and Serum Biomarker Measurements in Patients Undergoing Medical Thoracoscopy for Persistently Undiagnosed Pleural Effusion: A Pilot Study from a TB-Endemic Tertiary Centre. Pulm Ther. 2026 Oct 23. doi: 10.1007/s41030-026-00388-5. Online ahead of print.
Related trials for Medical Thoracoscopy
Not yet recruiting
Study of Medical Thoracoscopy in Early Pleural Infection
Pleural Infection
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
Not yet recruiting
Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease
Pleural Effusion Disorder
Not yet recruitingPhase 2/3
Ultrasound Guided Erectror Spinae Block Versus Intracavitary During Medical Thoracoscopy
PLEURA DISEASE
Not yet recruiting
Role of Medical Thoracoscopy in Pleural Infection (PROMPT Trial)
Pleural Infection, Pleural Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurmeet Singh, MD, Phd principal investigator
Dr Cipto Mangunkusumo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical thoracoscopy in people with Medical Thoracoscopy, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gurmeet Singh, MD, PhD (+6281385158159, gurmeetsingh10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To analyze role of medical thoracoscopy on undiagnosed transudative and exudative pleural effusion patients (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159179, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.