Video Assisted Thoracoscopic Decortication Versus Interventional Radiology Guided Chest Tube Insertion With Fibrinolytics for the Management of Empyema (DICE Trial)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• CT Chest confirming the presence of a parapneumonic effusion

• Diagnostic thoracentesis values: pH\<7.2, Glucose \<2.2mmol/L or LDH \>1000IU/L with the presence of pus

• Ability to undergo general anesthesia, no allergies to anesthetic agents or DNAse/streptokinase, no rapidly fatal underlying illness and the ability to tolerate single lung ventilation

Locations
Other Locations
Canada
Queen's University/Kingston Health Sciences Centre
RECRUITING
Kingston
Contact Information
Primary
Erin L Williams, MD
17es1@queensu.ca
5066457408
Backup
Wiley Chung, MD, FRCSC
wiley.chung@kingstonhsc.ca
1-613-549-6666
Time Frame
Start Date: 2021-08-24
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 70
Treatments
Active_comparator: IR guided chest tube insertion with fibrinolytics
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.
Active_comparator: VATS Decortication
Video assisted thorascopic surgery decortication (VATS) as primary intervention for empyema.
Related Therapeutic Areas
Sponsors
Leads: Dr. Wiley Chung

This content was sourced from clinicaltrials.gov