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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thirty days
Awards & highlights
DICE Trial 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.Check my eligibility
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.See study design
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.
DICE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ thirty days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thirty days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of re-intervention
Secondary outcome measures
Cost of Hospital Stay
Morbidity
Mortality
+1 moreDICE 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am showing signs of shock, like low blood pressure or confusion.I can have general anesthesia and single lung ventilation without any known allergies to anesthetics.I have had symptoms for over six weeks and a thick pleural peel seen on a chest CT.Your thoracentesis test results show very low pH or glucose levels, or very high LDH levels with pus present.I am under 18 years old.You have a chest CT that shows a buildup of fluid near your lungs due to pneumonia.
Research Study Groups:
This trial has the following groups:- Group 1: IR guided chest tube insertion with fibrinolytics
- Group 2: VATS Decortication
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently recruiting participants?
"Affirmative. Clinicaltrials.gov archives data that show this medical trial, which began on August 24th 2021, is still actively searching for participants. 70 patients are needed from one site in particular."
Answered by AI
Is there a limit to the amount of individuals taking part in this experiment?
"Affirmative. According to information stored on clinicaltrials.gov, this investigation is still seeking participants since it was initially posted in August of 2021 and updated last month. A total of 70 people are required for the single trial site involved with the study."
Answered by AI
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