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

NCT ID: NCT02165891

Last Updated: 2018-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-06-30

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.

Detailed Description

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Conditions

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Empyema, Pleural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Urokinase

insertion of a chest drain with urokinase instillation

Group Type OTHER

insertion of a chest drain with urokinase instillation

Intervention Type DRUG

Other interventions except drainage procedure are the same in both arms

VATS

primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms

Group Type OTHER

primary video-assisted thorascopic surgery

Intervention Type PROCEDURE

Interventions

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insertion of a chest drain with urokinase instillation

Other interventions except drainage procedure are the same in both arms

Intervention Type DRUG

primary video-assisted thorascopic surgery

Intervention Type PROCEDURE

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 :

1. fever continuing 48h after starting correct antibiotherapy
2. respiratory distress
3. 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Fabiola Children's University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen Fabiola University Children Hospital

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Nicolas Lefevre, MD

Role: primary

Other Identifiers

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P2013/PE1

Identifier Type: -

Identifier Source: org_study_id

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