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

2026年7月14日 更新者:Amir Soliman、Delta University for Science and Technology

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.

研究概览

详细说明

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:

  1. CT Volumetry (128-slice multidetector CT) will quantify affected lung volume and percentage of improvement.
  2. 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.

研究类型

介入性

注册 (实际的)

36

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Gamasa、埃及、1234
        • Delta University for Science and Technology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

-

Inclusion Criteria:

  1. Patient age between 18 and 62 years inclusive.
  2. Presence of a unilateral complicated parapneumonic pleural effusion (CPPE) requiring pleurolytic intervention.
  3. Imaging-confirmed pleural loculation on chest ultrasonography or computed tomography (CT).
  4. 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.
  5. 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:

  1. 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.
  2. Tuberculous pleural effusion.
  3. Transudative pleural effusion.
  4. Frozen chest syndrome or chronic trapped lung.
  5. Pregnancy.
  6. Known bleeding diathesis or uncorrected coagulopathy.
  7. Patient refusal or inability to provide written informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
实验性的: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.
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Composite Radiological Efficiency Score
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月26日

初级完成 (实际的)

2026年6月27日

研究完成 (实际的)

2026年6月27日

研究注册日期

首次提交

2026年6月28日

首先提交符合 QC 标准的

2026年7月14日

首次发布 (实际的)

2026年7月20日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

IPD 共享时间框架

Data will become available beginning 6 months after publication of the main trial results and will remain accessible for up to 36 months.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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