VATS Decortication vs. IR-Guided Chest Tube + Fibrinolytics for Empyema
(DICE Trial)
Trial Summary
What is the purpose of this trial?
The American Association of Thoracic Surgery defines empyema as pus in the pleural space. It is a common thoracic surgery presentation with an estimated 65,000 cases occurring annually in the United States. Despite the high prevalence of empyemas, there has been no consensus as to its optimal first line management. Methods of acceptable treatment currently include chest tube insertion (thoracostomy), thoracostomy with fibrinolytics, decortication via a thoracotomy (removal of fibrous peel on the lung) and 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 the initial treatments of Interventional Radiology (IR) guided chest tube insertion with intrapleural fibrinolytics (as per Multi-Institutional Sepsis 2 Trial; MIST 2 Trial) versus VATS decortication. Currently, either of these treatments is considered first-line depending on the surgeon and institutional preference.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment VATS Decortication vs. IR-Guided Chest Tube + Fibrinolytics for Empyema?
Research shows that both video-assisted thoracoscopic surgery (VATS) and chest tube drainage with fibrinolytics are effective in treating empyema, with VATS potentially offering greater benefits in advanced cases. Image-guided chest tubes have improved patient care by allowing precise placement and effective drainage, often avoiding the need for open surgery.12345
Is the treatment of empyema with VATS Decortication or IR-Guided Chest Tube with Fibrinolytics safe?
Both VATS Decortication and IR-Guided Chest Tube with Fibrinolytics are generally considered safe for treating empyema, with image-guided techniques improving patient care and reducing the need for more invasive surgery. Patients typically tolerate these procedures well, especially when performed by skilled operators, and they often avoid open surgery.12346
How does the treatment of VATS Decortication vs. IR-Guided Chest Tube + Fibrinolytics for empyema differ from other treatments?
This treatment is unique because it combines interventional radiology-guided chest tube insertion with fibrinolytics (medications that help break down blood clots) and video-assisted thoracoscopic surgery (VATS) decortication, which is a minimally invasive surgical procedure to remove infected tissue. While both approaches are used separately in practice, this trial explores their combined use to potentially enhance treatment effectiveness for empyema, especially in advanced cases.35789
Research Team
Erin Williams, MD
Principal Investigator
Queens University
Wiley Chung, MD, FRCSC
Principal Investigator
Queens University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either image-guided chest tube insertion with fibrinolytics or VATS decortication as primary intervention for empyema
Follow-up
Participants are monitored for safety and effectiveness after treatment, including re-intervention rates and mortality
Extended Follow-up
Monitoring for resolution of empyema and other secondary outcomes
Treatment Details
Interventions
- Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics
- Video assisted thorascopic decortication
Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics is already approved in United States, European Union for the following indications:
- Empyema in the fibrinopurulent phase
- Empyema in the fibrinopurulent phase
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr. Wiley Chung
Lead Sponsor
Dr. Wiley Chung
Lead Sponsor