A Prospective Observational Study on the Role of Transthoracic Ultrasound in Differentiating Tuberculous From Malignant Pleural Effusion

NCT05935696 | Unknown

• 1 other identifier: TUS-TBE v4.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion; Tuberculosis, Pleural; Malignant Pleural Effusion

Keywords

pleural effusion; transthoracic ultrasound; tuberculous pleural effusion

Outcome Measures

Primary Outcomes (1)

• Transthoracic ultrasound

  To assess the prevalence and diagnostic performance of pre-determined echographic features in predicting the diagnosis of TBE from MPE.

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• All adult patients 18 years old or more
• Undiagnosed exudative pleural effusion planning for diagnostic medical thoracoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarawak General Hospital: lead
• Hospital Queen Elizabeth, Kota Kinabalu, Sabah: collaborator
• Institute of Respiratory Medicine Malaysia, Kuala Lumpur: collaborator
• Hospital Serdang, Selangor: collaborator
• University of Malaya: collaborator
• Hospital Melaka, Melaka: collaborator

Study Sites (1)

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

RECRUITING

MeSH Terms

Conditions

Pleural Effusion; Tuberculosis, Pleural; Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)