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Thoracoscopy Versus Fibrinolysis in Children With Empyema

NCT ID: NCT00323531

Last Updated: 2008-05-09

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Empyema

Keywords

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thoracoscopy fibrinolysis empyema children

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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1

Video assisted thoracoscopic decortication

Group Type ACTIVE_COMPARATOR

VATS decortication

Intervention Type PROCEDURE

thoracoscopic decortication

2

Fibrinolysis through the chest tube

Group Type EXPERIMENTAL

Chest tube with tPA infusion for 3 days

Intervention Type PROCEDURE

fibrinolysis through the chest tube

Interventions

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Chest tube with tPA infusion for 3 days

fibrinolysis through the chest tube

Intervention Type PROCEDURE

VATS decortication

thoracoscopic decortication

Intervention Type PROCEDURE

Other Intervention Names

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Fibrinolysis tPA VATS pleural debridement

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Children's Mercy Hospital

Principal Investigators

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Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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06 01-019

Identifier Type: -

Identifier Source: org_study_id