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

Primary Purpose

Empyema, Pleural

Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
insertion of a chest drain with urokinase instillation
primary video-assisted thorascopic surgery
Sponsored by
Queen Fabiola Children's University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Empyema, Pleural

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Fabiola University Children HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Urokinase

VATS

Arm Description

insertion of a chest drain with urokinase instillation

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

Outcomes

Primary Outcome Measures

duration of drainage

Secondary Outcome Measures

length of hospital stay
Duration of oxygen therapy
duration of intravenous antibiotic therapy
Duration of fever > 38.5°C
Number of Participants with Serious and Non-Serious Adverse Events
Patient discomfort

Full Information

First Posted
February 26, 2014
Last Updated
July 3, 2018
Sponsor
Queen Fabiola Children's University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02165891
Brief Title
Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children
Acronym
UROVATS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Fabiola Children's University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empyema, Pleural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Urokinase
Arm Type
Other
Arm Description
insertion of a chest drain with urokinase instillation
Arm Title
VATS
Arm Type
Other
Arm Description
primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms
Intervention Type
Drug
Intervention Name(s)
insertion of a chest drain with urokinase instillation
Intervention Description
Other interventions except drainage procedure are the same in both arms
Intervention Type
Procedure
Intervention Name(s)
primary video-assisted thorascopic surgery
Primary Outcome Measure Information:
Title
duration of drainage
Time Frame
end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days
Secondary Outcome Measure Information:
Title
length of hospital stay
Time Frame
Hospital departure with an expected average time of two weeks to one month
Title
Duration of oxygen therapy
Time Frame
up to the end of patient hospitalisation with an expected average time of 48 hours to five days
Title
duration of intravenous antibiotic therapy
Time Frame
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
Title
Duration of fever > 38.5°C
Time Frame
Up to fever resolution, with an average expected time of five days to 14 days
Title
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame
Up to the end of the hospitalisation, until three months corresponding to the end of follow up period
Title
Patient discomfort
Time Frame
Up to chest drain removal with an average expected time of 48 hours up to seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Queen Fabiola University Children Hospital
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Lefevre, MD
Email
nicolas.lefevre@huderf.be
First Name & Middle Initial & Last Name & Degree
Nicolas Lefevre, MD

12. IPD Sharing Statement

Learn more about this trial

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

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