drugset / Trial / NCT07713329

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

NCT07713329

Phase 2 Completed 36 enrolled Delta University for Science and Technology
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-03-26
Primary completion
2026-06-27
Completion
2026-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 8 mg Other
Subject Hydrogen Peroxide Small molecule 3 % Other
Subject Hydrogen Peroxide Small molecule 250 ml Other
Subject Hydrogen Peroxide Small molecule 300 ml Other
Subject Triamcinolone Acetonide Other / unclassified 0.3 mg/kg Other
Subject Triamcinolone Acetonide Other / unclassified 0.6 mg/kg Other