Diagnostic Yield of Agitated Exudative Non-infected Pleural Effusion

Not Applicable

Active, not recruiting

• Conditions: Pleural Effusion
• Interventions: Procedure: Agitated Pleural Fluid Thoracentesis

• Registration Number: NCT05819294
• Lead Sponsor: Alexandria University

Brief Summary

The goal of this study is to compare the diagnostic yield in terms of cellular content and biochemical characteristics of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The hypothesis is that the agitated fluid would be more representative and thus may aid the diagnosis of non-infected exudative pleural effusions.

Detailed Description

Transudation or exudation are the two mechanisms by which fluid accumulates, where Starling forces' imbalance is responsible for the former and inflammatory increase in capillary permeability accounts for the latter. Despite the history and presentation commonly suggesting the underlying etiology, pleural fluid aspiration and analysis is frequently required for confirmation of the nature and cause of the effusion. Aspirated pleural fluid is routinely subjected to biochemical analysis as well as microbiological and cytological analysis especially when infection or neoplasia is suspected. One drawback however to thoracentesis analysis is the relatively low diagnostic yield in different forms of exudative effusion. Tuberculous pleural effusions have a yield of \<10% on acid-fast bacilli smears and overall yield \<30% on solid culture. Conventional cytologic analysis from malignant pleural effusions also show a relatively low overall yield of around 51%, though this could be highly variable depending on the primary cancer involved (6% in mesothelioma - 80% in ovarian adenocarcinoma).In addition, it is not uncommon for analysis results to widely vary in the same patient in those with loculated and in malignant pleural effusions. This could be attributed to the compartmentalization in complex septated collections and heterogenous distribution of cellular components throughout the pleural space. The gold standard however in diagnosing unexplained exudative pleural effusions is pleural biopsy which is technically demanding and sometimes associated with longer hospital stay along with the increased incurred costs.

The investigators propose a method for improving the representativeness of pleural fluid samples via pleural agitation prior to aspiration in exudative noninfected pleural effusion. The aim is to test the feasibility and safety of using pleural fluid agitation prior to aspiration and to investigate the potential for an improved diagnostic yield using this novel thoracentesis technique in patients with exudative non-infected pleural effusion. A control group of 10 participants with transudative pleural effusion (based on history, clinical picture, and imaging) will be included to exclude any effect of the agitation procedure on the biochemical profile of the pleural fluid. These will include patients with uncontrolled heart failure, renal or hepatic impairment presenting with classical uncomplicated free pleural effusion.

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-01
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-19
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Age > 18 years old
2. At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)

Exclusion Criteria

1. Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
2. Hemodynamic instability
3. Pleural infection based on clinical presentation, imaging or laboratory investigations and pleural fluid examination showing glucose < 40 mg/dL or pH <7.2 with lower respiratory infection, positive gram stain or bacterial culture or pus on aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard thoracentesis followed by pre-aspiration fluid agitation	Agitated Pleural Fluid Thoracentesis	Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of the cytological analysis	14 days	Percentage of samples with a positive cytological result among both aspiration techniques
Diagnostic yield of the microbiolocal analysis (mycobacterial / fungal)	14 days	Percentage of samples with a evidence of mycobacterial / fungal elements among both aspiration techniques
Incidence of adverse events with pre-aspiration fluid agitation	14 days	Percentage of patients with incidence of adverse events during or right after pre-aspiration fluid agitation including pneumothorax or significant pain or cough or oxygen desaturation

Secondary Outcome Measures

Name	Time	Method
Neutrophilic count difference between both aspiration method	results within 1 day of sampling	Difference in neutrophilic count in the aspirated fluid via both techniques
Lymphocytic count difference between both aspiration method	results within 1 day of sampling	Difference in lymphocytic count in the aspirated fluid via both techniques
Protein level difference between both aspiration method	results within 1 day of sampling	Difference in Protein levels in the aspirated fluid via both techniques
Lactate dehydrogenase (LDH) level difference between both aspiration method	results within 1 day of sampling	Difference in LDH levels in the aspirated fluid via both techniques
Glusose level difference between both aspiration method	results within 1 day of sampling	Difference in glucose levels in the aspirated fluid via both techniques

Trial Locations

Locations (1)

Chest Diseases Department, Alexandria University Faculty of Medicine; 🇪🇬 Alexandria, Egypt