Pleural EffusionTUS-TBENCT05935696
A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion
An observational study of Pleural Effusion and Tuberculosis, Pleural, run by Sarawak General Hospital at 1 site in Malaysia.
Trial summary
Primary Endpoint To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE. To determine the clinical, pleural fluid and echographic parameters that were different among TBE and MPE and to establish a clinical prediction model for TBE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Tuberculosis, Pleural, Malignant Pleural Effusion
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2023to 31 Mar 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients more than 18 years old who presented with undiagnosed pleural effusion scheduled for diagnostic medical thoracoscopy in all respective sites during first quarter of 2023 for six months will be considered for inclusion.
Who may be able to join
- All adult patients 18 years old or more
- Undiagnosed exudative pleural effusion planning for diagnostic medical thoracoscopy
Who cannot join
- Patient less than 18 years old
- Patient for therapeutic medical thoracoscope (i.e., medical thoracoscopic adhesiolysis in patient with parapneumonic pleural effusion) in which diagnosis is already known.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
Sze Shyang Kho, MD, 6082276666, khosze@moh.gov.my
About this study
Primary Endpoint
- To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE.
- To determine the clinical, pleural fluid and echographic parameters that were different among TBE and MPE and to establish a clinical prediction model for TBE.
Secondary Endpoint
- To assess the correlation between pleural fluid parameters with ultrasound and medical thoracoscopic finding.
- To assess the optimal Pf ADA cut-off value to differentiate TBE from MPE in our region.
Read the detailed description
Tuberculous (TBE) and malignant pleural effusion (MPE) is the commonest cause of exudative pleural effusion in Malaysia. Early differentiation between these two diagnoses is essential as TBE only requires drainage if symptomatic, whereas MPE would require tissue biopsy for diagnosis confirmation and molecular profiling. However, both TBE and MPE present almost similarly with lymphocytic exudates. Pleural fluid (Pf) indices such as adenosine deaminase (ADA) may allow differentiation between these two entities in appropriate clinical circumstances. However, Pf ADA may not readily be accessible in resource-limited regions and the optimal cut-off varies depending on the local prevalence of tuberculosis. As a result, TBE diagnosis in our region is still heavily dependent on the analysis of pre-existing clinical demographic data and Pf parameters, where ultimately requiring pleural biopsy for a confident clinical diagnosis.
Point-of-care predictors for TBE, such as ultrasound imaging appearance, may be helpful, but have rarely been described. Previous studies have demonstrated that a complex septated ultrasound pattern in lymphocytic pleural effusion is a potentially useful diagnostic predictor to differentiate TBE from MPE with a positive predictive value of 94% and likelihood ratio of 12.2 TBE diagnostic algorithms frequently include only clinical indices with Pf parameters such as Pf differential cell count, ADA, protein and lactate dehydrogenase (LDH). Incorporation of point-of-care ultrasound finding into the clinical diagnostic algorithm has not been extensively explored.
TBE is the result of a delayed type IV hypersensitivity reaction to mycobacterial protein; fibrin formation in the pleural cavity is largely driven by pro-inflammatory cytokines as well as a reduction of fibrinolytic activity due to pleural inflammation. In contrast, MPE is believed to be driven by a high degree of anaerobic metabolism leading to lactic acid production, rather than an inflammatory response. These different pathogenic mechanisms in TBE and MPE resulted in different pleural fluid parameters such as lower Pf glucose and pH with higher Pf LDH level in MPE when compared to TBE. We believed that this principle may be extrapolated to discriminative ultrasound findings between TBE and MPE.
The result from our retrospective pilot study found that the presence of echographic septation had an adjusted odds ratio of 9.28 in prediction of TBE diagnosis from MPE. Along with other clinical parameters (male gender, serum leucocyte counts 9 x 109/L or, pleural fluid protein 50g/L or more), these parameters collectively report a diagnostic accuracy of 79.61% (95% CI 74.13-84.38) for TBE. In a previous study conducted in region with low tuberculosis burden, pleural thickening of >1cm, pleural nodularity and diaphragmatic thickening of >7mm on transthoracic ultrasound were highly suggestive of MPE. However, not uncommonly, we observed similar pattern of pleural and diaphragmatic thickening in TBE patients in our region as well.
As TBE is a hypersensitivity process with significant inflammatory response, we hypothesize that echographic septation, in addition to pleural thickening and other sonographic findings, may be a good indicator, as part of a clinical prediction model to discriminate TBE from MPE in our region.
- Keywords
- pleural effusion, transthoracic ultrasound, tuberculous pleural effusion
- Medical subject headings
- Pleural Effusion, Tuberculosis, Pleural, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tuberculous Pleural Effusion | Tuberculous pleural effusion (TBE) if any of the following criteria is presence: * Histological evidence of caseating granuloma from pleural biopsy * Microbiological evidence (positive growth of Mycobacterium tuberculosis culture, positive TB-PCR, positive Xpert MTB/RIF) from pleural fluid or pleural biopsy specimen * In patients with positive sputum smear for acid fast bacilli, sputum positive for mycobacterium tuberculosis culture, sputum positive for Xpert MTB/RIF or TB-PCR with no apparent cause of an exudative pleural effusion Patient without histological or microbiological evidence who demonstrated therapeutic response to anti-tuberculosis drugs will not be accepted as TBE in current study. | |
| Malignant Pleural Effusion (Control) | Malignant pleural effusion (MPE) if any of the following criteria is presence: • Histological or cytological evidence of specific histopathological diagnosis of malignancy from pleural biopsy Patient without histological or cytological evidence or malignancy (para-malignant) will not be considered as MPE in the context of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transthoracic ultrasound
To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarawak General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Institute of Respiratory Medicine Malaysia, Kuala Lumpur, Hospital Serdang, Selangor, University of Malaya, Hospital Melaka, Melaka
- Responsible party
- Principal investigator, Kho Sze Shyang, Sarawak General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935696
- Sponsor's protocol ID
- TUS-TBE v4.0
- Acronym
- TUS-TBE
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT05935696
- Acronym / sponsor ID
- TUS-TBE / TUS-TBE v4.0
- Keywords
- pleural effusion, transthoracic ultrasound, tuberculous pleural effusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sarawak General HospitalUniversity, hospital or other
- Collaborators
- Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Institute of Respiratory Medicine Malaysia, Kuala Lumpur, Hospital Serdang, Selangor, University of Malaya, Hospital Melaka, Melaka
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 7 Jul 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.
Primary Endpoint
- To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE.
- To determine the clinical, pleural fluid and echographic parameters that were different among TBE and MPE and to establish a clinical prediction model for TBE.
Secondary Endpoint
- To assess the correlation between pleural fluid parameters with ultrasound and medical thoracoscopic finding.
- To assess the optimal Pf ADA cut-off value to differentiate TBE from MPE in our region.
Detailed description
Tuberculous (TBE) and malignant pleural effusion (MPE) is the commonest cause of exudative pleural effusion in Malaysia. Early differentiation between these two diagnoses is essential as TBE only requires drainage if symptomatic, whereas MPE would require tissue biopsy for diagnosis confirmation and molecular profiling. However, both TBE and MPE present almost similarly with lymphocytic exudates. Pleural fluid (Pf) indices such as adenosine deaminase (ADA) may allow differentiation between these two entities in appropriate clinical circumstances. However, Pf ADA may not readily be accessible in resource-limited regions and the optimal cut-off varies depending on the local prevalence of tuberculosis. As a result, TBE diagnosis in our region is still heavily dependent on the analysis of pre-existing clinical demographic data and Pf parameters, where ultimately requiring pleural biopsy for a confident clinical diagnosis.
Point-of-care predictors for TBE, such as ultrasound imaging appearance, may be helpful, but have rarely been described. Previous studies have demonstrated that a complex septated ultrasound pattern in lymphocytic pleural effusion is a potentially useful diagnostic predictor to differentiate TBE from MPE with a positive predictive value of 94% and likelihood ratio of 12.2 TBE diagnostic algorithms frequently include only clinical indices with Pf parameters such as Pf differential cell count, ADA, protein and lactate dehydrogenase (LDH). Incorporation of point-of-care ultrasound finding into the clinical diagnostic algorithm has not been extensively explored.
TBE is the result of a delayed type IV hypersensitivity reaction to mycobacterial protein; fibrin formation in the pleural cavity is largely driven by pro-inflammatory cytokines as well as a reduction of fibrinolytic activity due to pleural inflammation. In contrast, MPE is believed to be driven by a high degree of anaerobic metabolism leading to lactic acid production, rather than an inflammatory response. These different pathogenic mechanisms in TBE and MPE resulted in different pleural fluid parameters such as lower Pf glucose and pH with higher Pf LDH level in MPE when compared to TBE. We believed that this principle may be extrapolated to discriminative ultrasound findings between TBE and MPE.
The result from our retrospective pilot study found that the presence of echographic septation had an adjusted odds ratio of 9.28 in prediction of TBE diagnosis from MPE. Along with other clinical parameters (male gender, serum leucocyte counts 9 x 109/L or, pleural fluid protein 50g/L or more), these parameters collectively report a diagnostic accuracy of 79.61% (95% CI 74.13-84.38) for TBE. In a previous study conducted in region with low tuberculosis burden, pleural thickening of >1cm, pleural nodularity and diaphragmatic thickening of >7mm on transthoracic ultrasound were highly suggestive of MPE. However, not uncommonly, we observed similar pattern of pleural and diaphragmatic thickening in TBE patients in our region as well.
As TBE is a hypersensitivity process with significant inflammatory response, we hypothesize that echographic septation, in addition to pleural thickening and other sonographic findings, may be a good indicator, as part of a clinical prediction model to discriminate TBE from MPE in our region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuberculous Pleural Effusion | – | –Tuberculous pleural effusion (TBE) if any of the following criteria is presence: * Histological evidence of caseating granuloma from pleural biopsy * Microbiological evidence (positive growth of Mycobacterium tuberculosis culture, positive TB-PCR, positive Xpert MTB/RIF) from pleural fluid or pleural biopsy specimen * In patients with positive sputum smear for acid fast bacilli, sputum positive for mycobacterium tuberculosis culture, sputum positive for Xpert MTB/RIF or TB-PCR with no apparent cause of an exudative pleural effusion Patient without histological or microbiological evidence who demonstrated therapeutic response to anti-tuberculosis drugs will not be accepted as TBE in current study. |
| Malignant Pleural Effusion (Control) | – | –Malignant pleural effusion (MPE) if any of the following criteria is presence: • Histological or cytological evidence of specific histopathological diagnosis of malignancy from pleural biopsy Patient without histological or cytological evidence or malignancy (para-malignant) will not be considered as MPE in the context of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients more than 18 years old who presented with undiagnosed pleural effusion scheduled for diagnostic medical thoracoscopy in all respective sites during first quarter of 2023 for six months will be considered for inclusion.
Key inclusion criteria (2 listed)
- All adult patients 18 years old or more
- Undiagnosed exudative pleural effusion planning for diagnostic medical thoracoscopy
Key exclusion criteria (2 listed)
- Patient less than 18 years old
- Patient for therapeutic medical thoracoscope (i.e., medical thoracoscopic adhesiolysis in patient with parapneumonic pleural effusion) in which diagnosis is already known.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transthoracic ultrasound
Time frame: 12 months
To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Pleural Effusion
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Tuberculosis, Pleural, run by Sarawak General Hospital at 1 site in Malaysia.
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 2 inclusion and 2 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 7 Jul 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 Malaysia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transthoracic ultrasound (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2023.