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NCT07713329

Overview

NCT ID: NCT07713329
Lead Sponsor: Delta University for Science and TechnologyOTHER
Official Title: Liberation of Captive Pleura: Chemical Pleural Adhesiolysis Versus Mechanical Pleural Adhesiolysis in Stacked Pleural Effusion
Brief Summary: The purpose of this study is to compare the clinical and radiological efficacy of chemical pleural adhesiolysis (using either intrapleural 3% hydrogen peroxide or intrapleural corticosteroids) versus mechanical pleural adhesiolysis (via medical thoracoscopy) in patients with non-malignant, complicated parapneumonic pleural effusion (CPPE).

Complicated pleural effusions often lead to the formation of fibrinous septa and adhesions, which impair drainage and prevent lung re-expansion. Standard interventions like tissue plasminogen activator (tPA) and DNase can be costly and limited in resource-constrained settings, while thoracoscopic mechanical pleurolysis requires specialized expertise and equipment.

The investigators aim to evaluate whether chemical adhesiolysis using accessible, cost-effective agents (hydrogen peroxide or steroids) can offer a comparable and reliable alternative to thoracoscopic mechanical disruption of septa. Efficacy will be assessed using a novel composite clinical and radiological efficiency score evaluated seven days post-procedure.

Status and Timeline

Status: Completed
Last Update Posted: Jul 20, 2026Actual
Start Date: Mar 26, 2026Actual
Primary Completion Date: Jun 27, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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Inclusion Criteria:

Patient age between 18 and 62 years inclusive.

Presence of a unilateral complicated parapneumonic pleural effusion (CPPE) requiring pleurolytic intervention.

Imaging-confirmed pleural loculation on chest ultrasonography or computed tomography (CT).

Pleural fluid biochemical or microbiological indicators of complicated effusion, defined by at least one of the following: pleural fluid pH < 7.2, glucose < 60 mg/dL, and/or a positive Gram stain or culture.

Absolute histopathological or cytological exclusion of malignant and tuberculous pleural disease prior to enrollment (verified via closed pleural biopsy and/or image-guided pleural biopsy based on clinical presentation).

Exclusion Criteria:

Confirmed malignant pleural effusion or features highly suggestive of malignancy (e.g., pleural nodularity, circumferential pleural thickening > 10 mm, mediastinal pleural involvement, or associated pulmonary masses) not yet fully evaluated.

Tuberculous pleural effusion.

Transudative pleural effusion.

Frozen chest syndrome or chronic trapped lung.

Pregnancy.

Known bleeding diathesis or uncorrected coagulopathy.

Patient refusal or inability to provide written informed consent.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 36Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Delta university for science and technology

Similar Studies

Participant Group/Arms

Group A: Hydrogen Peroxide-Mediated PleurolysisExperimental

Participants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural 3% hydrogen peroxide instilled via an existing intercostal drain.

Drug: Intrapleural Hydrogen Peroxide (H_2O_2)

Group B: Steroid-Mediated PleurolysisExperimental

Participants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural corticosteroids (dexamethasone or triamcinolone acetonide) instilled via an existing intercostal drain.

Drug: Intrapleural Corticosteroids

Group C: Thoracoscopic Mechanical PleurolysisExperimental

Participants with unilateral complicated parapneumonic pleural effusion randomized to undergo medical thoracoscopy for direct vision-guided mechanical disruption of fibrinous septa and adhesions.

Procedure: Thoracoscopic Mechanical Pleurolysis