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.
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: 1. CT Volumetry (128-slice multidetector CT) will quantify affected lung volume and percentage of improvement. 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Diluted pharmaceutical-grade 3% hydrogen peroxide solution. A total volume of 250-300 mL is instilled via an intercostal chest tube (accounting for tube dead space to deliver approximately 250 mL directly into the pleural cavity). Administered in 2 sessions, spaced 24 hours apart, with a 4-6 hour chest tube clamping window per session.
Administered via an existing intercostal drain. Corticosteroid agent used is 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. Administered in 2 sessions, spaced 24 hours apart, with a 4-6 hour chest tube clamping window per session.
Performed under local anesthesia and conscious sedation. Involves medical thoracoscopy for direct vision-guided mechanical disruption of fibrinous septa and adhesions, evacuation of loculations, and placement of an intercostal drain.
Delta university for science and technology
Gamasa, Egypt
Composite Radiological Efficiency Score
Treatment efficiency is evaluated using a study-defined composite clinical/radiological score ranging from 0 to 6. The score integrates 5 domains: (1) Lung volumetric improvement, (2) Diaphragmatic excursion improvement, (3) Pleural thickness reduction, and (4) Drained pleural fluid volume. For these first four domains, a percentage change/improvement from baseline equals or more than 30% is assigned 1 point, while a change \< 30% is assigned 0 points. The 5th domain is Effusion complexity, scored sonographically as: septated = 0, complex = 1, and simple = 2. Higher total scores indicate a greater pleurolytic response, with treatment success classified as a total score equals or more than 5.
Time frame: 7 days post-intervention
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