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

NCT07713329 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Pleural Infection
  • Pleural Adhesions
  • Pleural Effusion
  • Pleural Empyema

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.

Sponsors & Collaborators

  • Delta University for Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07713329 on ClinicalTrials.gov