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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

No Placebo-Only Group

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.

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I have had symptoms for over six weeks and a thick pleural peel seen on a chest CT.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ thirty days

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

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: 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.

0 / 3Eligibility criteria met