Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children

Study Overview
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Brief Summary
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Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial. The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.

Official Title
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Prospective Randomized Study Comparing the Efficacy and Safety of Pleural Drainage by Video-Assisted Thoracoscopic With Pleural Drainage by Percutaneous Drain Associated With Urokinase in the Treatment of Parapneumonic Pleural Effusion in Children

Conditions
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Empyema, Pleural

Intervention / Treatment
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* Drug: insertion of a chest drain with urokinase instillation
* Procedure: primary video-assisted thorascopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients under the age of 17 pleural fluid depth of at least 15mm, confirmed by ultrasound at least one of the following severity criteria : fever continuing 48h after starting correct antibiotherapy respiratory distress mediastinal displacement on the chest X-ray Exclusion Criteria: previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment congenital pulmonary disorders with lung function impairment chronic pulmonary disease associated with lung function impairment hemodynamic instability congenital immunodeficiency disease secondary immune deficiency induced hemostasis disorder (contraindication of thrombolytic therapy) pregnancy or breastfeeding patient

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Urokinase<br>insertion of a chest drain with urokinase instillation | Drug: insertion of a chest drain with urokinase instillation<br>* Other interventions except drainage procedure are the same in both arms<br>|
| Other: VATS<br>primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms | Procedure: primary video-assisted thorascopic surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of drainage |  | end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  | Hospital departure with an expected average time of two weeks to one month | 
| Duration of oxygen therapy |  | up to the end of patient hospitalisation with an expected average time of 48 hours to five days | 
| duration of intravenous antibiotic therapy |  | up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month | 
| Duration of fever > 38.5°C |  | Up to fever resolution, with an average expected time of five days to 14 days | 
| Number of Participants with Serious and Non-Serious Adverse Events |  | Up to the end of the hospitalisation, until three months corresponding to the end of follow up period | 
| Patient discomfort |  | Up to chest drain removal with an average expected time of 48 hours up to seven days |