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Thoracoscopy Versus Fibrinolysis in Children With Empyema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323531
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : May 9, 2008
Information provided by:
Children's Mercy Hospital Kansas City

Brief Summary:
The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for empyema recover in the same amount of time. Therefore, we will test this by randomizing the next 40 patients who consent to the study to one treatment or the other.

Condition or disease Intervention/treatment Phase
Empyema Procedure: Chest tube with tPA infusion for 3 days Procedure: VATS decortication Phase 2 Phase 3

Detailed Description:

This will be a single institution, prospective, randomized clinical trial involving patients who are found to have at least a single septation within a pleural effusion as diagnosed by ultrasound or computed tomography. Additionally, patients with a pleural effusion wherein a pleural tap reveals pus as defined by many (> 10,000/mm3 ) white blood cells or positive cultures will be considered. This is intended to be a definitive study.

Power calculations based on the known 4.8 post intervention hospital days after VATS and the estimated 7 post intervention days after fibrinolysis with α = 0.05 and power of 0.8 show the need for 18 patients in each arm. We will intend to recruit 40. This sample size was constructed in consultation with Dr. Steve Simon, and the range of hospital stay in our retrospective experience was utilized. Therefore, this number should represent an adequate power in spite of the known varied level of illness.

One group will undergo thoracoscopy to clean the pleural space and leave a chest tube postoperatively to drainage. The other group will undergo chest tube placement with subsequent infusion of fibrinolytics to dissolve the thick purulent material allowing drainage.

Both groups will have the same antibiotic regimen with the same management algorithm.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoracoscopy Versus Fibrinolysis in Children With Empyema
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
Active Comparator: 1
Video assisted thoracoscopic decortication
Procedure: VATS decortication
thoracoscopic decortication
Other Names:
  • VATS
  • pleural debridement

Experimental: 2
Fibrinolysis through the chest tube
Procedure: Chest tube with tPA infusion for 3 days
fibrinolysis through the chest tube
Other Names:
  • Fibrinolysis
  • tPA

Primary Outcome Measures :
  1. Length of hospitalization after intervention [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Days where a maximum temperature was equal to or above 38 degrees C, days of tube drainage, doses of analgesia and days of oxygen requirement, hospital days after intervention, hospital charges after intervention and procedure charges [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients less than 18 years of age requiring an intervention for empyema by one of the following:

    1. Septation or loculation seen on ultrasound or computed tomography
    2. Many white blood cells, bacteria present, or thick viscid purulence identified on pleural tap

Exclusion Criteria:

  1. Immunodeficiency process
  2. Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
  3. Existing contraindications to VATS or chest tube.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323531

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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
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Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
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Responsible Party: Shawn St. Peter, Children's Mercy Hospital Identifier: NCT00323531    
Other Study ID Numbers: 06 01-019
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008
Keywords provided by Children's Mercy Hospital Kansas City:
Additional relevant MeSH terms:
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Pathologic Processes