70 Participants Needed

VATS Decortication vs. IR-Guided Chest Tube + Fibrinolytics for Empyema

(DICE Trial)

EL
WC
Overseen ByWiley Chung, MD, FRCSC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dr. Wiley Chung
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

EW

Erin Williams, MD

Principal Investigator

Queens University

WC

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

I can have general anesthesia and single lung ventilation without any known allergies to anesthetics.
Your thoracentesis test results show very low pH or glucose levels, or very high LDH levels with pus present.
You have a chest CT that shows a buildup of fluid near your lungs due to pneumonia.

Exclusion Criteria

I am showing signs of shock, like low blood pressure or confusion.
Participants cannot participate in any other clinical trials during the trial period
I have had symptoms for over six weeks and a thick pleural peel seen on a chest CT.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive either image-guided chest tube insertion with fibrinolytics or VATS decortication as primary intervention for empyema

3 days
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including re-intervention rates and mortality

30 days
Follow-up assessments

Extended Follow-up

Monitoring for resolution of empyema and other secondary outcomes

Up to 24 weeks

Treatment Details

Interventions

  • Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics
  • Video assisted thorascopic decortication
Trial OverviewThe 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.
Participant Groups
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.

Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as IR guided chest tube insertion with fibrinolytics for:
  • Empyema in the fibrinopurulent phase
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Interventional radiology guided chest tube insertion with intrapleural fibrinolytics for:
  • Empyema in the fibrinopurulent phase

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr. Wiley Chung

Lead Sponsor

Trials
2
Recruited
120+

Dr. Wiley Chung

Lead Sponsor

Trials
2
Recruited
120+

Findings from Research

Image-guided chest tubes significantly enhance the management of empyema by allowing effective drainage with minimal tissue dissection, leading to better patient tolerance and outcomes.
The success of this intervention relies on careful patient selection, skilled operators, and daily monitoring of chest tube function, which can often prevent the need for more invasive open surgical procedures.
Image-guided drainage techniques.Moulton, JS.[2016]
In a study of 285 children with parapneumonic effusion or empyema, real-time ultrasound-guided chest drain placement achieved a high success rate of 93% after a single drain, and 98.2% with two or three drains, indicating its effectiveness as a treatment option.
The procedure was found to be safe, with only five minor peri-insertion complications reported, and since 2012, all patients have been successfully treated with single-tube drainage, eliminating the need for surgical intervention.
Real-time ultrasound-guided pigtail catheter chest drain for complicated parapneumonic effusion and empyema in children - 16-year, single-centre experience of radiologically placed drains.Lewis, MR., Micic, TA., Doull, IJM., et al.[2018]
A prospective, randomized trial involving children with empyema found no significant differences in recovery outcomes between video-assisted thoracoscopic surgery (VATS) and fibrinolytic therapy, indicating both methods are equally effective.
Fibrinolysis may be safer, as no patients in that group worsened after treatment, while VATS was associated with higher medical costs and some complications, suggesting fibrinolysis should be considered the first-line treatment for pediatric empyema.
Thoracoscopic decortication vs tube thoracostomy with fibrinolysis for empyema in children: a prospective, randomized trial.St Peter, SD., Tsao, K., Spilde, TL., et al.[2021]

References

Image-guided drainage techniques. [2016]
Real-time ultrasound-guided pigtail catheter chest drain for complicated parapneumonic effusion and empyema in children - 16-year, single-centre experience of radiologically placed drains. [2018]
Thoracoscopic decortication vs tube thoracostomy with fibrinolysis for empyema in children: a prospective, randomized trial. [2021]
Intrapleural fibrinolytics combined with image-guided chest tube drainage for pleural infection. [2013]
Thoracoscopic decortication for advanced pediatric empyema. [2010]
The role of video-assisted thoracoscopic surgery in the treatment of parapneumonic empyema after the failure of fibrinolytics. [2008]
Experience with an evidence-based protocol using fibrinolysis as first line treatment for empyema in children. [2019]
Cost-Effectiveness Analysis of Fibrinolysis vs Thoracoscopic Decortication for Early Empyema. [2022]
Video-assisted thoracoscopic surgical decortication in the elderly with thoracic empyema: Five years' experience. [2019]