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NCT Number: NCT07449624

From Presentation to Diagnosis: Patterns of Pleural Effusion

Pleural effusion is a common clinical condition characterized by the accumulation of excess fluid within the pleural space due to disruption of normal pleural fluid dynamics. The etiology is diverse and includes systemic conditions such as congestive heart failure, liver cirrhosis, and renal disease, as well as localized pleural pathologies including infection, malignancy, and inflammatory disorders. Accurate classification of pleural effusion into transudative and exudative types, primarily using biochemical parameters such as Light's criteria, remains the cornerstone of diagnostic evaluation and guides subsequent clinical management.

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Key information

About this study

Recent evidence emphasizes that differentiation based on biochemical and radiological characteristics significantly influences clinical decision-making. Exudative effusions usually reflect pleural inflammation or injury and often require further diagnostic procedures, such as cytological examination or thoracoscopy, to determine specific causes including malignancy or tuberculosis. In contrast, transudative effusions are typically associated with systemic disorders and are generally managed by treating the underlying condition.

Although Light's criteria continue to serve as the standard diagnostic tool, ongoing research seeks to refine diagnostic thresholds and explore adjunctive biochemical markers and imaging modalities to improve sensitivity and specificity in distinguishing effusion types and identifying underlying etiologies.

Several international studies have described the epidemiology and causes of pleural effusion across different populations; however, data from Egypt remain limited, particularly from tertiary care centers such as Mansoura University Hospitals. Understanding the patterns and etiologies of pleural effusion within a specific population-especially in regions with distinct epidemiological characteristics-is essential from both scientific and clinical perspectives.

Accurate categorization into transudative and exudative effusions using biochemical and imaging criteria allows clinicians to tailor the diagnostic approach appropriately. While transudative effusions often require conservative management targeting the primary systemic condition, exudative effusions frequently necessitate more invasive investigations, including pleural biopsy, thoracoscopy, or advanced imaging techniques to establish a definitive diagnosis.

Such stratification helps minimize unnecessary invasive procedures, reduce diagnostic delays, and optimize healthcare resource utilization-particularly in settings with limited access to advanced interventional diagnostics. Furthermore, local data regarding prevalence and clinical presentation provide valuable insights into regional disease burdens, such as higher rates of tuberculosis or malignancy, thereby supporting more effective healthcare planning and targeted management protocols.

Finally, adopting a comprehensive approach that integrates clinical assessment, radiological findings, and pleural fluid analysis aligns with contemporary evidence-based recommendations for pleural disease evaluation, ensuring that the study findings are applicable to both local and international clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with documented pleural effusion confirmed by chest imaging (X-ray, ultrasound, or CT).
  • Patients with complete clinical, laboratory, and radiological records.

Exclusion criteria

  • Patients with incomplete medical records.
  • Pediatric patients (<18 years).
  • Patients with post-surgical pleural collections unrelated to systemic or pathological causes.

Treatment and study plan

Pleural effusion pathology

Diagnostic Test

describe the demographic and clinical characteristics of patients presenting with pleural effusion.

To classify pleural effusions into transudates and exudates using Light's criteria.

To determine the most common etiologies of pleural effusion in Mansoura University.

To evaluate the relationship between clinical presentation, radiological findings,

Primary outcomes

  1. Distribution of underlying etiologies of pleural effusion among patients treated at Mansoura University Hospitals

    Time frame: 5 years

    Number of patients diagnosed with each underlying cause of pleural effusion (e.g., malignancy, tuberculosis, parapneumonic effusion, heart failure, liver cirrhosis, renal failure, and others) based on clinical evaluation, radiological findings, and pleural fluid analysis.

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

From Presentation to Diagnosis: Patterns and Etiologies of Pleural Effusion - A Retrospective Study at Mansoura University

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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