Comparing VATS surgery and drainage for treating pleural empyema

Intrapleural Fibrinolysis and DNase Versus VATS for the Treatment of Pleural Empyema: a Randomized, Controlled Trial

This study is testing whether a type of surgery called VATS works better than standard drainage methods for helping patients with pleural empyema feel better and recover their lung function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aarhus University Hospital (Academic / other)
• Locations: 3 sites (Aarhus, Aarhus and 2 other locations)
• Trial ID: NCT04095676 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Video Assisted Thoracoscopic Surgery (VATS) compared to standard drainage methods for patients with pleural empyema, particularly in stages II and III of the disease. The study will involve randomizing participants to receive either VATS or drainage with intrapleural fibrinolytic therapy. The goal is to determine which treatment provides better outcomes in terms of infection removal and lung expansion. The trial is being conducted at multiple hospitals in Denmark, focusing on patients who have been hospitalized for acute pleural infections.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been hospitalized with a diagnosis of community-acquired pleural infection.

Not a fit: Patients who are pregnant, breastfeeding, terminally ill, or have had previous intrathoracic surgery within the last year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with pleural empyema, potentially reducing morbidity and mortality rates.

How similar studies have performed: Previous studies have shown positive effects of combining fibrinolytic therapy with DNase, but the comparison of VATS to drainage in this context is still under clinical evaluation.

Eligibility criteria

Inclusion Criteria:

* 18 years or more on the day of hospitalization
* Must be able to provide informed consent
* Acute hospitalization within the last 48 hours
* Meeting diagnostic criteria for community acquired pleural infection using the following criteria:

  1. A clinical presentation compatible with pleural infection AND
  2. Has pleural fluid which is either:

     1. purulent pleural fluid or
     2. gram stain positive or
     3. culture positive or
     4. acidic with pH \< 7.2 or
     5. low pleural fluid glucose (\< 2 mmol/L) in the absence of accurate pH measurement or
     6. septated pleural fluid on ultrasound

Exclusion Criteria:

* • Pregnancy. Prior to inclusion of fertile women (defined as the period from menarche to postmenopause) a negative pregnancy test must be available
* Breastfeeding
* Declared terminally ill or a predicted survival of less than 3 months
* Previous intrathoracic surgery (within \<1 year on the same side of the thorax as where the parapneumonic effusion/pleural empyema is located
* Previously (within \<1 year) hospitalized with with complex parapneumonic effusion (stage II) or pleural empyema (stage III)
* Drainage during the current admission on the same side of the thorax (excluding diagnostic pleural puncture)
* Hospitalization within 7 days prior to current hospitalization
* Previous allergic reaction to alteplase or DNase
* Use of alteplase therapy contraindicated:

  * Ongoing treatment with oral anticoagulant incl. new oral anticoagulants (e.g. warfarin (Marevan), Dabigatranetexilat (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), Endoxaban (Lixiana))
  * Significant ongoing bleeding or within last six months
  * Known haemorrhagic diathesis
  * Previous or suspected intracranial hemorrhage
  * Suspected subarachnoidal hemorrhage or condition following subarachnoidal hemorrhage from aneurysm
  * All forms of damage to the central nervous system (e.g. cerebral tumors, aneurysm, intracranial / spinal surgery)
  * Recent (within 10 days) cardiac resuscitation, birth, or perforation of non-compressible blood vessel (e.g. puncture of v. subclavia, v. jugularis)
  * Severe, uncontrolled arterial hypertension
  * Bacterial endocarditis, pericarditis
  * Acute pancreatitis
  * Documented ulcerative gastrointestinal disease within last 3 months, esophagal varices, arterial aneurysm, arterio-venous malformations
  * Tumor / malignancy with an increased risk of hemorrhage
  * Severe liver disease, including liver failure cirrhosis, portal hypertension (esophagal varices), and active hepatitis
  * Large operation or significant trauma within previous 3 months

Where this trial is running

Aarhus, Aarhus and 2 other locations

• Aarhus University Hospital — Aarhus, Aarhus, Denmark (Recruiting)
• Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
• Odense University Hospital — Odense, Denmark (Recruiting)

Study contacts

• Principal investigator: Christian B Laursen, MD, PhD — Odense University Hospital
• Study coordinator: Thomas D Christensen, MD, PhD

Conditions Pleural Empyema