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

Queen Fabiola Children's University Hospital

Status and phase: Unknown; Phase 3

Conditions: Empyema, Pleural

Treatments: Procedure: primary video-assisted thorascopic surgery; Drug: insertion of a chest drain with urokinase instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT02165891

P2013/PE1

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Urokinase

Other group

Description:

insertion of a chest drain with urokinase instillation

Treatment:

Drug: insertion of a chest drain with urokinase instillation

VATS

Other group

Description:

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

Treatment:

Procedure: primary video-assisted thorascopic surgery