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COMPLETED
NCT07713329
PHASE2

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

Sponsor: Delta University for Science and Technology

View on ClinicalTrials.gov

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.

Official title: Liberation of Captive Pleura: Chemical Pleural Adhesiolysis Versus Mechanical Pleural Adhesiolysis in Stacked Pleural Effusion

Key Details

Gender

All

Age Range

18 Years - 62 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-03-26

Completion Date

2026-06-27

Last Updated

2026-07-20

Healthy Volunteers

Yes

Interventions

DRUG

Intrapleural Hydrogen Peroxide (H_2O_2)

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.

DRUG

Intrapleural Corticosteroids

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.

PROCEDURE

Thoracoscopic Mechanical Pleurolysis

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.

Locations (1)

Delta university for science and technology

Gamasa, Egypt