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Trial Title:
A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion
NCT ID:
NCT05935696
Condition:
Pleural Effusion
Tuberculosis, Pleural
Malignant Pleural Effusion
Conditions: Official terms:
Tuberculosis
Tuberculosis, Pleural
Pleural Effusion, Malignant
Pleural Effusion
Conditions: Keywords:
pleural effusion
transthoracic ultrasound
tuberculous pleural effusion
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- All adult patients 18 years old or more
- Undiagnosed exudative pleural effusion planning for diagnostic medical thoracoscopy
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Sarawak General Hospital
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Sze Shyang Kho, MD
Phone:
6082276666
Email:
khosze@moh.gov.my
Start date:
April 1, 2023
Completion date:
March 31, 2024
Lead sponsor:
Agency:
Sarawak General Hospital
Agency class:
Other
Collaborator:
Agency:
Hospital Queen Elizabeth, Kota Kinabalu, Sabah
Agency class:
Other
Collaborator:
Agency:
Institute of Respiratory Medicine Malaysia, Kuala Lumpur
Agency class:
Other
Collaborator:
Agency:
Hospital Serdang, Selangor
Agency class:
Other
Collaborator:
Agency:
University Malaya Medical Center, Selangor
Agency class:
Other
Collaborator:
Agency:
Hospital Melaka, Melaka
Agency class:
Other
Source:
Sarawak General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05935696
