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Procedure

VATS Decortication vs. IR-Guided Chest Tube + Fibrinolytics for Empyema (DICE Trial)

N/A
Recruiting
Led By Wiley Chung, MD, FRCSC
Research Sponsored by Dr. Wiley Chung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Exhibiting signs of shock (hypotension, altered mental state etc)
Symptoms for six weeks or longer with a pleural peel on CT chest of ≥ 10mm thick as this would preclude patients to be better managed by thoracotomy rather than VATS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thirty days
Awards & highlights

Summary

This trial is comparing two methods of treating empyema, which is pus in the pleural space. The first method is chest tube insertion with intrapleural fibrinolytics, and the second is video-assisted thoracoscopic surgery (VATS) decortication. The investigators aim to determine the rate of re-intervention within thirty days for adults presenting with empyema in the fibrinopurulent phase by comparing these two methods.

Who is the study for?
Adults with empyema, which is pus in the pleural space of the lungs, confirmed by a CT scan and specific lab values from thoracentesis. Participants must be able to undergo general anesthesia without allergies to anesthetic agents or DNAse/streptokinase, have no rapidly fatal illness, and tolerate single lung ventilation.
What is being tested?
The trial compares two treatments for adults with empyema: video-assisted thoracoscopic surgery (VATS) decortication versus interventional radiology guided chest tube insertion with fibrinolytics. The goal is to see which treatment better prevents the need for additional interventions within thirty days.
What are the potential side effects?
Potential side effects may include complications related to general anesthesia, reactions at the site of surgical intervention or chest tube insertion, bleeding, infection risk increase due to invasive procedures, and possible damage to surrounding tissues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am showing signs of shock, like low blood pressure or confusion.
Select...
I have had symptoms for over six weeks and a thick pleural peel seen on a chest CT.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thirty days
This trial's timeline: 3 weeks for screening, Varies for treatment, and thirty days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of re-intervention
Secondary study objectives
Cost of Hospital Stay
Morbidity
Mortality
+1 more

Trial Design

2Treatment groups
Active Control
Group I: IR guided chest tube insertion with fibrinolyticsActive Control1 Intervention
Image guided chest tube insertion by interventional radiology along with MIST 2 trial fibrinolysis which includes intrapleural dornase (5mg) and Alteplase (10mg) every twelve hours for a total of six doses as primary intervention for empyema.
Group II: VATS DecorticationActive Control1 Intervention
Video assisted thorascopic surgery decortication (VATS) as primary intervention for empyema.

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Who is running the clinical trial?

Dr. Wiley ChungLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Erin Williams, MDStudy DirectorQueens University
Wiley Chung, MD, FRCSCPrincipal InvestigatorQueens University

Media Library

Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03584113 — N/A
Pleural Empyema Research Study Groups: IR guided chest tube insertion with fibrinolytics, VATS Decortication
Pleural Empyema Clinical Trial 2023: Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics Highlights & Side Effects. Trial Name: NCT03584113 — N/A
Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03584113 — N/A
~15 spots leftby Aug 2025
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