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

NCT03584113 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

OTHER

Video assisted thorascopic decortication

Video assisted thorascopic decortication surgery 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).

Sponsors & Collaborators

  • Dr. Wiley Chung

    lead OTHER

Principal Investigators

  • Wiley Chung, MD, FRCSC · Queens University

  • Erin Williams, MD · Queens University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2025-08-01
Completion
2025-09-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584113 on ClinicalTrials.gov