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VATS Decortication Versus IR Guided Chest Tube Insertion With Fibrinolytics for the Management of Empyema (DICE)

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ClinicalTrials.gov Identifier: NCT03584113
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Wiley Chung, Queen's University

Brief 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.

Condition or disease Intervention/treatment Phase
Empyema, Pleural Other: Video assisted thorascopic decortication Other: Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Video Assisted Thoracoscopic Decortication Versus Interventional Radiology Guided Chest Tube Insertion With Fibrinolytics for the Management of Empyema (DICE Trial)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Arm Intervention/treatment
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.
Other: Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics
Image guided chest tube insertion by IVR with intrapleural fibrinolytics (six doses of dornase [5mg] and alteplase [10mg] Q12hours).

Active Comparator: VATS Decortication
Video assisted thorascopic surgery decortication (VATS) as primary intervention for empyema.
Other: Video assisted thorascopic decortication
Video assisted thorascopic decortication surgery as primary intervention for empyema
Other Name: VATS Decortication




Primary Outcome Measures :
  1. Rate of re-intervention [ Time Frame: Thirty Days ]
    Requiring chest tube (+/-repeat), VATs decortication (+/-repeat), or thoracotomy


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: Thirty Days ]
    post-intervention/ hospital complications

  2. Mortality [ Time Frame: Thirty Days ]
    post-intervention/ Hospital mortality

  3. Resolution of Empyema [ Time Frame: Up to 24 weeks ]
    Time to resolution of empyema

  4. Cost of Hospital Stay [ Time Frame: Measure from time to presentation to hospital to time of discharge ]
    Total costs calculated during hospital stay as a measure of global hospital costs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584113


Contacts
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Contact: Erin L Sproul, MD 5066457408 17es1@queensu.ca
Contact: Wiley Chung, MD, FRCSC 1-613-549-6666 ext 2383 wiley.chung@kingstonhsc.ca

Locations
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Canada, Ontario
Queen's University/Kingston Health Sciences Centre Not yet recruiting
Kingston, Ontario, Canada, K7L2V7
Contact: Leah Garrison    6135496666 ext 8171    leah.garrison@kingstonhsc.ca   
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Wiley Chung, MD, FRCSC Queens University
Study Director: Erin Sproul, MD Queens University

Publications:

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Responsible Party: Dr. Wiley Chung, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT03584113     History of Changes
Other Study ID Numbers: 6023903
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data collected will be kept and analyzed amongst the co-investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Empyema
Empyema, Pleural
Suppuration
Infection
Inflammation
Pathologic Processes
Respiratory Tract Infections
Pleural Diseases
Respiratory Tract Diseases