Chemical vs Mechanical Pleural Adhesiolysis for Liberation of Captive Pleura in Stacked Effusion

This is a parallel-group, open-label, single-blinded (radiological and ultrasonographic assessors), pilot randomized controlled clinical trial conducted at the Chest Medicine Department, Mansoura University Hospital.

A total of 36 eligible adult patients (aged 18-62 years) presenting with unilateral complicated parapneumonic pleural effusion requiring pleurolytic intervention will be randomized in a 1:1:1 ratio into one of three treatment arms (12 patients per arm):

• Group A (Hydrogen Peroxide-Mediated Pleurolysis): Patients will receive intrapleural instillation of 250-300 mL of 3% hydrogen peroxide (diluted with sterile saline) via an existing intercostal drain after the initial drainage phase. The tube will be clamped for 4-6 hours while the patient alternates positions (supine and lateral decubitus) to optimize distribution. This protocol will be repeated 24 hours later for a total of two sessions.
• Group B (Steroid-Mediated Pleurolysis): Patients will receive intrapleural instillation of either Dexamethasone 8 mg or Triamcinolone acetonide 0.3-0.6 mg/kg (approximately 80 mg), diluted in normal saline to a total volume of 250-300 mL via the intercostal drain.

Clamping, positional rotation, and dosing intervals (two sessions 24 hours apart) will be identical to Group A.

● Group C (Thoracoscopic Mechanical Pleurolysis): Patients will undergo medical thoracoscopy under local anesthesia and conscious sedation. This involves direct visual exploration of the pleural cavity, mechanical disruption of fibrinous septa/adhesions, evacuation of loculated fluid, and subsequent placement of an intercostal drain.

Assessments will be conducted at baseline (pre-intervention) and at 7 days post-procedure to evaluate treatment response:

• CT Volumetry (128-slice multidetector CT) will quantify affected lung volume and percentage of improvement.
• Chest Ultrasonography (B-mode and M-mode) will measure fractional pleural thickness reduction and diaphragmatic excursion.

The primary outcome will be evaluated using a 0-6 point composite clinical/radiological efficiency score at day 7, combining lung volumetric improvement, diaphragmatic excursion, pleural thickness reduction, drained fluid volume, and resolution of effusion complexity. Patients who fail chemical pleurolysis (Group A or B) will be offered crossover to mechanical pleurolysis as a rescue intervention.

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.