Ignite Creation Date:
2024-05-06 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05935696
Status:
RECRUITING
Last Update Posted:
2023-07-07
First Post:
2023-06-28
Brief Title:
A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion
Sponsor:
Sarawak General Hospital
Organization:
Sarawak General Hospital
Study Overview
Official Title:
A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TUS-TBE
Brief 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
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 122 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 928 in prediction of TBE diagnosis from MPE Along with other clinical parameters male gender serum leucocyte counts 9 x 109L or pleural fluid protein 50gL or more these parameters collectively report a diagnostic accuracy of 7961 95 CI 7413-8438 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
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 122 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 928 in prediction of TBE diagnosis from MPE Along with other clinical parameters male gender serum leucocyte counts 9 x 109L or pleural fluid protein 50gL or more these parameters collectively report a diagnostic accuracy of 7961 95 CI 7413-8438 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None