Operative VATS decortication for Pleural Malignant Mesothelioma

N/A

Waitlist Available

Led By Fredric Pieracci, MD, MPH

Research Sponsored by Denver Health and Hospital Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.

Awards & highlights

No Placebo-Only Group

Summary

This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.

Eligible Conditions

Pleural Malignant Mesothelioma
Pleural Empyema
Parapneumonic Effusion
Blood Clotting Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Length of Stay

Secondary study objectives

Changed in Coagulopathic Status

Chest Tube Days

Chest Tube Drainage

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Operative VATS decorticationActive Control1 Intervention

Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema

Group II: Non-operative Fibrinolytic TherapyActive Control1 Intervention

Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.

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