Chemical vs Mechanical Pleural Adhesiolysis for Liberation of Captive Pleura in Stacked Effusion
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Gamasa, Egypt, 1234
- Delta University for Science and Technology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
-
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group A: Hydrogen Peroxide-Mediated Pleurolysis
Participants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural 3% hydrogen peroxide instilled via an existing intercostal drain.
|
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.
|
|
Eksperimentell: Group B: Steroid-Mediated Pleurolysis
Participants with unilateral complicated parapneumonic pleural effusion randomized to receive intrapleural corticosteroids (dexamethasone or triamcinolone acetonide) instilled via an existing intercostal drain.
|
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.
|
|
Eksperimentell: Group C: Thoracoscopic Mechanical Pleurolysis
Participants with unilateral complicated parapneumonic pleural effusion randomized to undergo medical thoracoscopy for direct vision-guided mechanical disruption of fibrinous septa and adhesions.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite Radiological Efficiency Score
Tidsramme: 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.
|
7 days post-intervention
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R.26.03.3607
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .