Quantitative C-Reactive Protein for Differentiating Tuberculous and Malignant Pleural Effusion: a Cross-Sectional Study

Maharajgunj Medical Campus

Status: Completed

Conditions: Malignant Pleural Effusions; Pleural Effusion; Tuberculous Pleural Effusion

Treatments: Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement

Study type: Observational

Funder types: Other

Identifiers

NCT06729931

225(6-11)E2079/080

Details and patient eligibility

About

The goal of this observational study is to evaluate the role of pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels in distinguishing between tuberculous and malignant pleural effusion in adult patients with lymphocytic exudative pleural effusion.

The main questions it aims to answer are:

Is pleural fluid Q-CRP significantly higher in tuberculous pleural effusion compared to malignant pleural effusion? What is the optimal cutoff value of pleural fluid Q-CRP to differentiate between these conditions?

Participants will:

Undergo diagnostic procedures such as pleural fluid analysis, including ADA and cytology.

Provide pleural fluid samples for Q-CRP measurement. Have additional diagnostic imaging or biopsies if clinically indicated.

Researchers will compare Q-CRP levels between the tuberculous pleural effusion group and the malignant pleural effusion group to determine its diagnostic accuracy, including sensitivity, specificity, and predictive value.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years and older.
• Patients presenting with lymphocytic exudative pleural effusion confirmed by Light's criteria.
• Lymphocyte predominance in pleural fluid (≥ 50% of differential count).

Exclusion criteria

• Patients who refuse to provide consent for study participation.
• Patients requiring biopsy under general anesthesia but found unfit for the procedure.
• Non-tuberculous and non-malignant lymphocytic exudative pleural effusions identified during diagnostic evaluation.

Trial design

81 participants in 2 patient groups

Tuberculous Pleural Effusion

Description:

Patients diagnosed with tuberculous pleural effusion based on pleural fluid ADA, AFB/GeneXpert, or pleural/lung tissue biopsy.

Treatment:

Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement

Malignant Pleural Effusion

Description:

Patients diagnosed with malignant pleural effusion through pleural fluid cytology or pleural/lung tissue biopsy, supported by radiological findings.

Treatment:

Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement