Pleural InfectionPhase 2NCT07713329
Chemical vs Mechanical Pleural Adhesiolysis for Liberation of Captive Pleura in Stacked Effusion
A Phase 2 study testing Intrapleural Hydrogen Peroxide (H_2O_2), Intrapleural Corticosteroids and Thoracoscopic Mechanical Pleurolysis in people with Pleural Infection and Pleural Adhesions, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Pleural Infection, Pleural Adhesions, Pleural Effusion
- What is being tested?
- Intrapleural Hydrogen Peroxide (H_2O_2), Intrapleural Corticosteroids and Thoracoscopic Mechanical Pleurolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2026to 27 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- 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.
- Absolute histopathological or cytological exclusion of malignant and tuberculous pleural disease prior to enrollment (verified via closed pleural biopsy and/or image-guided pleural biopsy based on clinical presentation).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liberation of Captive Pleura: Chemical Pleural Adhesiolysis Versus Mechanical Pleural Adhesiolysis in Stacked Pleural Effusion
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.
Read the detailed description
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:
- CT Volumetry (128-slice multidetector CT) will quantify affected lung volume and percentage of improvement.
- 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.
- Being tested
- Intrapleural Hydrogen Peroxide (H_2O_2), Intrapleural Corticosteroids, Thoracoscopic Mechanical Pleurolysis
- Keywords
- Medical Thoracoscopy, Pleural Effusion, Empyema, Adhesiolysis, Pleural Decortication, Pleurolysis, Pleural Adhesions
- Medical subject headings
- Pleural Effusion, Empyema, Pleural, Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Intrapleural CorticosteroidsDrug
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.
Thoracoscopic Mechanical PleurolysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Thoracoscopic Mechanical Pleurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start26 Mar 2026
- Primary completion27 Jun 2026
- Study completion27 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Soliman, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713329
- Sponsor's protocol ID
- R.26.03.3607
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the final published manuscript (including text, tables, and figures) will be made available to qualified medical researchers to facilitate secondary academic reviews or meta-analyses.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberation of Captive Pleura: Chemical Pleural Adhesiolysis Versus Mechanical Pleural Adhesiolysis in Stacked Pleural Effusion
- ClinicalTrials.gov ID
- NCT07713329
- Acronym / sponsor ID
- R.26.03.3607
- Keywords
- Medical Thoracoscopy, Pleural Effusion, Empyema, Adhesiolysis, Pleural Decortication, Pleurolysis, Pleural Adhesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 27 Jun 2026 (actual)
- Study completion
- 27 Jun 2026 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- CT Volumetry (128-slice multidetector CT) will quantify affected lung volume and percentage of improvement.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: Hydrogen Peroxide-Mediated Pleurolysis | Experimental | Drug: Intrapleural Hydrogen Peroxide (H_2O_2)Participants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural 3% hydrogen peroxide instilled via an existing intercostal drain. |
| Group B: Steroid-Mediated Pleurolysis | Experimental | Drug: Intrapleural CorticosteroidsParticipants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural corticosteroids (dexamethasone or triamcinolone acetonide) instilled via an existing intercostal drain. |
| Group C: Thoracoscopic Mechanical Pleurolysis | Experimental | Procedure: Thoracoscopic Mechanical PleurolysisParticipants with unilateral complicated parapneumonic pleural effusion randomized to undergo medical thoracoscopy for direct vision-guided mechanical disruption of fibrinous septa and adhesions. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- -
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group A: Hydrogen Peroxide-Mediated Pleurolysis |
| Intrapleural CorticosteroidsAdministered 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. | Drug | Group B: Steroid-Mediated Pleurolysis |
| Thoracoscopic Mechanical PleurolysisPerformed 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. | Procedure or surgery | Group C: Thoracoscopic Mechanical Pleurolysis |
Primary outcome
Composite Radiological Efficiency Score
Time frame: 7 days post-intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- European Respiratory Society (ERS) clinical review on complicated pleural effusions management.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the final published manuscript (including text, tables, and figures) will be made available to qualified medical researchers to facilitate secondary academic reviews or meta-analyses.
Related trials for Pleural Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 4
VATS or Intrapleural Enzymatic Therapy for Patients With Empyema.
Empyema, Pleural, Pleural Infections
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Not yet recruiting
Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
Pleural Empyema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrapleural Hydrogen Peroxide (H_2O_2), Intrapleural Corticosteroids and Thoracoscopic Mechanical Pleurolysis in people with Pleural Infection and Pleural Adhesions, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Radiological Efficiency Score (time frame: 7 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.