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

(DICE Trial)

Overseen By Wiley Chung, MD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Wiley Chung

Disqualifiers: Under 18, Pregnant, Shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 days

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two ways to treat empyema, a condition where pus accumulates around the lungs. The study compares two methods: one uses a chest tube placed by imaging guidance with medicine to break up the pus (interventional radiology guided chest tube insertion with fibrinolytics), and the other involves a surgical procedure called VATS, which removes the pus and any fibrous tissue (video-assisted thoracoscopic decortication). The goal is to determine which method results in fewer repeat treatments within 30 days. The trial seeks adults diagnosed with empyema who can safely undergo anesthesia, excluding those with symptoms for six weeks or more. As an unphased trial, it offers participants the chance to contribute to important medical research that could enhance treatment options for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments under study for empyema are safe.

For chest tube insertion guided by interventional radiology, studies indicate that patients generally tolerate this method well. It uses medications like dornase and Alteplase to break down clots in the chest. These medications are commonly used, and their side effects are usually easy to manage. Most patients experience only minor issues, making this a safe choice for many.

Similarly, video-assisted thoracoscopic surgery (VATS) decortication has a strong safety record. Research indicates that this minimally invasive surgery, which removes a fibrous layer on the lung, results in fewer complications than traditional open surgery. Patients undergoing VATS often face fewer problems post-surgery, and the need for additional surgeries is rare.

Both treatments have proven to be safe and effective first-line options for managing empyema. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for empyema because they offer innovative approaches to managing this condition. The interventional radiology-guided chest tube insertion with fibrinolytics is unique as it uses image guidance for precise placement and combines with fibrinolytic drugs, Dornase and Alteplase, to effectively break down pleural fluid collections. This method is less invasive compared to traditional surgery and can be performed under local anesthesia. On the other hand, Video Assisted Thorascopic Surgery (VATS) decortication offers a minimally invasive surgical option that directly removes the thickened pleural layers, potentially leading to quicker recovery and less postoperative pain compared to open surgery. Both treatments aim to improve patient outcomes with less invasiveness than conventional options.

What evidence suggests that this trial's treatments could be effective for empyema?

This trial will compare two treatments for empyema: interventional radiology-guided chest tube insertion with fibrinolytics and video-assisted thoracoscopic surgery (VATS) decortication. The MIST 2 trial showed that using a chest tube with imaging technology and specific medicines, such as dornase and Alteplase, can be very effective. This method helps break down pus and improve drainage, reducing the need for additional surgery. Alternatively, VATS, which involves removing the thick layer around the lung, is also a strong option. Research suggests that VATS can lead to better outcomes compared to traditional open surgery for empyema, with fewer complications and faster recovery. Both treatments are effective, but the best choice might depend on individual patient needs and doctor recommendations. ^{1 3 4 6 7}

Who Is on the Research Team?

Wiley Chung, MD, FRCSC

Principal Investigator

Queens University

Erin Williams, MD

Principal Investigator

Queens University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics
• Video assisted thorascopic decortication

Trial Overview 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.

How Is the Trial Designed?

Group I: IR guided chest tube insertion with fibrinolytics Active Control 1 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 Decortication Active Control 1 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:

Approved in United States as IR guided chest tube insertion with fibrinolytics for:

• Empyema in the fibrinopurulent phase

Approved in European Union as Interventional radiology guided chest tube insertion with intrapleural fibrinolytics for:

• Empyema in the fibrinopurulent phase

Who Is Running the Clinical Trial?

Dr. Wiley Chung

Lead Sponsor

Trials

2

Recruited

120+

Dr. Wiley Chung

Lead Sponsor

Trials

2

Recruited

120+

Published Research Related to This Trial

In a retrospective review of 102 children with empyema treated with fibrinolysis, only 15.7% required subsequent video-assisted thoracoscopic surgery (VATS), indicating that most cases can be managed effectively without surgery.

Fibrinolytic therapy showed no major side effects, supporting its safety and efficacy as a first-line treatment for pediatric empyema, consistent with previous trial results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with an evidence-based protocol using fibrinolysis as first line treatment for empyema in children. Gasior, AC., Knott, EM., Sharp, SW., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 25 pediatric patients with stage 3 or 4 empyema, video-assisted thoracoscopic (VATS) decortication demonstrated a low morbidity rate of 16% and no deaths, indicating its safety as a treatment option.

Patients treated with VATS had a mean time to recovery of 3.2 days and were discharged on average by postoperative day 9, suggesting that VATS is an effective and efficient first-line management strategy for advanced empyema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracoscopic decortication for advanced pediatric empyema. Plackett, TP., Holt, DB., Johnson, SM., et al.[2010]

Video-assisted thoracoscopic surgery (VATS) decortication is an effective treatment for thoracic empyema in elderly patients, with a low 30-day mortality rate of 3% observed in a study of 33 patients aged 65 and older.

Postoperative complications primarily included respiratory failure and septic shock, highlighting the need for careful monitoring in this age group, but 75% of patients showed good lung re-expansion three months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-assisted thoracoscopic surgical decortication in the elderly with thoracic empyema: Five years' experience. Tsai, CH., Lai, YC., Chang, SC., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided drainage techniques. Moulton, JS.[2016]

In a study of 30 patients with pleural infection, the combination of image-guided chest tube drainage and intrapleural fibrinolytics (urokinase or tissue-type plasminogen activator) effectively resolved infections without the need for surgery in any cases.

The treatment resulted in a low mortality rate of 10% due to complications, and the median hospital stay was 11 days, indicating a generally safe and effective approach to managing pleural infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrapleural fibrinolytics combined with image-guided chest tube drainage for pleural infection. Levinson, GM., Pennington, DW.[2013]

Intrapleural fibrinolysis using tissue plasminogen activator and deoxyribonuclease is more cost-effective than video-assisted thoracoscopic surgery (VATS) decortication for treating early empyema, despite VATS having a slightly lower cost.

Fibrinolysis showed higher effectiveness at one year post-treatment (health utility of 0.80) compared to VATS decortication (0.71), suggesting that it may lead to better long-term outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of Fibrinolysis vs Thoracoscopic Decortication for Early Empyema. Shipe, ME., Maiga, AW., Deppen, SA., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 20 patients with complicated parapneumonic effusion and pleural empyema who did not respond to fibrinolytic treatment, video-assisted thoracoscopic surgery (VATS) successfully achieved complete drainage in 85% of cases.

VATS was found to be a safe and effective procedure, with a mean operative time of 80.3 minutes and an average postoperative hospital stay of 7.5 days, indicating it is a viable option for patients requiring more invasive intervention after fibrinolytic failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of video-assisted thoracoscopic surgery in the treatment of parapneumonic empyema after the failure of fibrinolytics. Bouros, D., Antoniou, KM., Chalkiadakis, G., et al.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03584113

VATS Decortication Versus IR Guided Chest Tube Insertion ... Image guided chest tube insertion by interventional radiology along with MIST 2 trial fibrinolysis which includes intrapleural dornase (5mg) and Alteplase (10mg) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865421000788

Study protocol for DICE trial: Video-assisted thoracoscopic ... We present a study protocol for a randomized control trial (RCT) comparing adult individuals with empyema to one of two standard of care initial management ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4982861/

Making the transition from video-assisted thoracoscopic ... There is ongoing variation in the use of video-assisted thoracoscopic surgery (VATS) and chest tube with fibrinolytics (CTWF) for empyema in children.

4. iosrjournals.org iosrjournals.org/iosr-jdms/papers/Vol17-issue4/Version-4/N1704047781.pdf

Radiologically Guided Chest Tube Insertion with ... Abstract: Tittle; Radiologically guided chest tube insertion with fibrinolytic instillation for loculated pleural effusion/empyema.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803737

Effect of Intrapleural Fibrinolytic Therapy vs Surgery for ... This randomized clinical trial compares chest tube drainage of the pleural cavity using intrapleural fibrinolytic therapy and surgical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8105624/

Study protocol for DICE trial: Video-assisted thoracoscopic ... We present a study protocol for a randomized control trial (RCT) comparing adult individuals with empyema to one of two standard of care initial management ...

7. journal.chestnet.org journal.chestnet.org/article/S0012-3692(09)60617-6/fulltext

Interventional Management of Pleural Infections - CHEST Blind chest tube insertion is now reserved for patients with large, free-flowing effusions at institutions that lack the resources for image-guided drainage.