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

NCT03584113 | Unknown DMC

• 1 other identifier: 6023903
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Empyema, Pleural

Outcome Measures

Primary Outcomes (1)

• Rate of re-intervention

  Requiring chest tube (+/-repeat), VATs decortication (+/-repeat), or thoracotomy

  Thirty Days

Secondary Outcomes (4)

• Morbidity

  Thirty Days

• Mortality

  Thirty Days

• Resolution of Empyema

  Up to 24 weeks

• Cost of Hospital Stay

  Measure from time to presentation to hospital to time of discharge

Study Arms (2)

IR guided chest tube insertion with fibrinolytics

ACTIVE COMPARATOR

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

VATS Decortication

ACTIVE COMPARATOR

Video assisted thorascopic surgery decortication (VATS) as primary intervention for empyema.

Other: Video assisted thorascopic decortication

Interventions

Video assisted thorascopic decortication OTHER

Video assisted thorascopic decortication surgery as primary intervention for empyema

Also known as: VATS Decortication

VATS Decortication

Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics OTHER

Image guided chest tube insertion by IVR with intrapleural fibrinolytics (six doses of dornase \[5mg\] and alteplase \[10mg\] Q12hours).

IR guided chest tube insertion with fibrinolytics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Wiley Chung: lead

Study Sites (1)

Queen's University/Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

RECRUITING

Related Publications (10)

• Ahmed S, Azam H, Basheer I. Is open decortication superior to fibrinolytic therapy as a first line treatment in the management of pleural empyema? Pak J Med Sci. 2016 Mar-Apr;32(2):329-32. doi: 10.12669/pjms.322.9676.

  PMID: 27182233 BACKGROUND

• Chambers A, Routledge T, Dunning J, Scarci M. Is video-assisted thoracoscopic surgical decortication superior to open surgery in the management of adults with primary empyema? Interact Cardiovasc Thorac Surg. 2010 Aug;11(2):171-7. doi: 10.1510/icvts.2010.240408. Epub 2010 May 3.

  PMID: 20439299 BACKGROUND

• Corcoran JP, Psallidas I, Wrightson JM, Hallifax RJ, Rahman NM. Pleural procedural complications: prevention and management. J Thorac Dis. 2015 Jun;7(6):1058-67. doi: 10.3978/j.issn.2072-1439.2015.04.42.

  PMID: 26150919 BACKGROUND

• Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.

  PMID: 20696688 BACKGROUND

• Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.

  PMID: 21830966 BACKGROUND

• Redden MD, Chin TY, van Driel ML. Surgical versus non-surgical management for pleural empyema. Cochrane Database Syst Rev. 2017 Mar 17;3(3):CD010651. doi: 10.1002/14651858.CD010651.pub2.

  PMID: 28304084 BACKGROUND

• Scarci M, Abah U, Solli P, Page A, Waller D, van Schil P, Melfi F, Schmid RA, Athanassiadi K, Sousa Uva M, Cardillo G. EACTS expert consensus statement for surgical management of pleural empyema. Eur J Cardiothorac Surg. 2015 Nov;48(5):642-53. doi: 10.1093/ejcts/ezv272. Epub 2015 Aug 7.

  PMID: 26254467 BACKGROUND

• Semenkovich TR, Olsen MA, Puri V, Meyers BF, Kozower BD. Current State of Empyema Management. Ann Thorac Surg. 2018 Jun;105(6):1589-1596. doi: 10.1016/j.athoracsur.2018.02.027. Epub 2018 Mar 14.

  PMID: 29550205 BACKGROUND

• Shen KR, Bribriesco A, Crabtree T, Denlinger C, Eby J, Eiken P, Jones DR, Keshavjee S, Maldonado F, Paul S, Kozower B. The American Association for Thoracic Surgery consensus guidelines for the management of empyema. J Thorac Cardiovasc Surg. 2017 Jun;153(6):e129-e146. doi: 10.1016/j.jtcvs.2017.01.030. Epub 2017 Feb 4. No abstract available.

  PMID: 28274565 BACKGROUND

• Wait MA, Sharma S, Hohn J, Dal Nogare A. A randomized trial of empyema therapy. Chest. 1997 Jun;111(6):1548-51. doi: 10.1378/chest.111.6.1548.

  PMID: 9187172 BACKGROUND

MeSH Terms

Conditions

Empyema, Pleural

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wiley Chung, MD, FRCSC

  Queens University

  PRINCIPAL INVESTIGATOR

• Erin Williams, MD

  Queens University

  STUDY DIRECTOR

Central Study Contacts

Erin L Williams, MD

CONTACT

5066457408; 17es1@queensu.ca

Wiley Chung, MD, FRCSC

CONTACT

1-613-549-6666; wiley.chung@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2018
• First Posted: July 12, 2018
• Study Start: August 24, 2021
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)