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

NCT07713329 | Completed Phase 2 DMC

• 1 other identifier: R.26.03.3607
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Medical Thoracoscopy; Pleural Effusion; Empyema; Adhesiolysis; Pleural Decortication; Pleurolysis; Pleural Adhesions

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days post-intervention

Study Arms (3)

Group A: Hydrogen Peroxide-Mediated Pleurolysis

EXPERIMENTAL

Participants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural 3% hydrogen peroxide instilled via an existing intercostal drain.

Drug: Intrapleural Hydrogen Peroxide (H_2O_2)

Group B: Steroid-Mediated Pleurolysis

EXPERIMENTAL

Participants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural corticosteroids (dexamethasone or triamcinolone acetonide) instilled via an existing intercostal drain.

Drug: Intrapleural Corticosteroids

Group C: Thoracoscopic Mechanical Pleurolysis

EXPERIMENTAL

Participants with unilateral complicated parapneumonic pleural effusion randomized to undergo medical thoracoscopy for direct vision-guided mechanical disruption of fibrinous septa and adhesions.

Procedure: Thoracoscopic Mechanical Pleurolysis

Interventions

Intrapleural Corticosteroids DRUG

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.

Group B: Steroid-Mediated Pleurolysis

Thoracoscopic Mechanical Pleurolysis PROCEDURE

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.

Group C: Thoracoscopic Mechanical Pleurolysis

Intrapleural Hydrogen Peroxide (H_2O_2) DRUG

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.

Group A: Hydrogen Peroxide-Mediated Pleurolysis

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Delta university for science and technology

Gamasa, 1234, Egypt

Location

Related Links

• European Respiratory Society (ERS) clinical review on complicated pleural effusions management.

MeSH Terms

Conditions

Pleural Effusion; Empyema, Pleural; Empyema

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This is a parallel-group, three-arm, pilot randomized controlled clinical trial with a 1:1:1 allocation ratio. Eligible participants are assigned to one of three distinct, independent treatment pathways (Group A: Hydrogen Peroxide, Group B: Corticosteroids, or Group C: Medical Thoracoscopy). Participants remain in their assigned treatment arm for the duration of the 7-day post-procedural assessment period to evaluate comparative efficacy. Crossover to mechanical pleurolysis is strictly reserved as a rescue clinical standard of care for patients who experience chemical treatment failure after data endpoints are established.

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 20, 2026
• Study Start: March 26, 2026
• Primary Completion: June 27, 2026
• Study Completion: June 27, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 6 months after publication of the main trial results and will remain accessible for up to 36 months.
• Access Criteria: IPD will be shared upon reasonable formal request directed to the principal investigator. Requests must include a methodologically sound research proposal and a signed data access agreement to ensure ethical compliance.

Locations

EG (1)