Liberation of Captive Pleura: Chemical Pleural Adhesiolysis Versus Mechanical Pleural Adhesiolysis in Stacked Pleural Effusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Composite Radiological Efficiency Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
- •Known bleeding diathesis or uncorrected coagulopathy.
- •Patient refusal or inability to provide written informed consent.
结局指标
主要结局
Composite Radiological Efficiency Score
时间窗: 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.
次要结局
未报告次要终点
研究者
Amir Soliman
Associate professor
Delta University for Science and Technology