Comparing two methods for treating empyema
Video Assisted Thoracoscopic Decortication Versus Interventional Radiology Guided Chest Tube Insertion With Fibrinolytics for the Management of Empyema (DICE Trial)
NA · Queen's University · NCT03584113
This study is testing whether a new type of surgery or a special chest tube treatment works better for adults with empyema to see which one helps them recover faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University (other) |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT03584113 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of video-assisted thoracoscopic surgery (VATS) decortication versus interventional radiology-guided chest tube insertion with fibrinolytics in adults with empyema in the fibrinopurulent phase. The study will assess the rate of re-intervention within thirty days following these treatments. Participants must have specific diagnostic criteria indicating the presence of empyema and be able to undergo general anesthesia. The trial seeks to address the ongoing debate regarding the optimal first-line management for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of empyema in the fibrinopurulent phase.
Not a fit: Patients with chronic empyema or those exhibiting signs of shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for the most effective treatment of empyema, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown success with fibrinolytic therapy in treating empyema, indicating that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Younger than age 18 * Pregnant * Symptoms for six weeks or longer with a pleural peel on CT chest of ≥ 10mm thick as this would preclude patients to be better managed by thoracotomy rather than VATS * Exhibiting signs of shock (hypotension, altered mental state etc) * Participants cannot participate in any other clinical trials during the trial period
Where this trial is running
Kingston, Ontario
- Queen's University/Kingston Health Sciences Centre — Kingston, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Wiley Chung, MD, FRCSC — Queens University
- Study coordinator: Erin L Williams, MD
- Email: 17es1@queensu.ca
- Phone: 5066457408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Empyema, Pleural