Recruiting

VATS vs. IR Guided

Sponsor:

Dr. Wiley Chung

Code:

NCT03584113

Conditions

Empyema, Pleural

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Video assisted thorascopic decortication

Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics

Study Details

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

Study ID

NCT03584113

Start date

Aug 24, 2021

Status verified date

Nov, 2023

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Video assisted thorascopic decortication

Video assisted thorascopic decortication surgery as primary intervention for empyema

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).

Primary outcome measure

  • Rate of re-intervention [ Time Frame: Thirty Days ]

Central Contacts and Locations

Central contacts

Locations

Queen's University/Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L2V7

Contacts

More Information

Sponsor

Dr. Wiley Chung

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Wiley Chung on 2023-11-18.