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RECRUITING

NCT04095676

VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema

Sponsor: Thomas Decker Christensen

View on ClinicalTrials.gov

Summary

Pleura empyema is a frequent disease with a high morbidity and a mortality rate of approximately 15%. Pleura empyema is characterized by the passage of three stages (I - III). The aim of treating the disease is to remove the infection and provide fully expansion of the lung. The initial treatment at the early stage of the disease (stage I) is simple drainage. In clinical practice, stages II and III are treated alike. Current standard treatment for these stages is drainage with ultrasound (ULS) -guided pigtail. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of Video Assisted Thoracoscopic Surgery (VATS). The theoretical advantage of early surgery is that patients undergo rapid, definitive treatment. Furthermore, surgery can ensure optimal drain placement. How best to treat these patients (drainage or surgery) is still under clinical evaluation and depends to a great extent on local clinical practice. It is only to a limited extent based on scientific evidence. The aim of this study is to determine if there is a difference in outcome in patients diagnosed with stage II and stage III empyema who either receive primary VATS surgery or ULS guided drainage and intrapleural therapy (fibrinolytic (altaplasm) with DNase (Pulmozyne ®)) The primary outcome is Hospitalization time and secondary outcomes is e.g. mortality, health related costs and quality of life. The present study can thus provide new and highly relevant knowledge as well as change the treatment of these patients, both nationally and internationally. It is planned that a total of 184 patients will be included in the project. The study takes place as a collaboration between all four thoracic surgical departments and the major pulmonary medicine departments in Denmark. In addition, the study has international collaborators/consultants who will provide counselling in connection with the study.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2022-10-30

Completion Date

2028-10-30

Last Updated

2025-10-03

Healthy Volunteers

Conditions

Pleural Empyema

Interventions

PROCEDURE

VATS group

VATS procedure with drainage, including rinse with NaCl

PROCEDURE

Drain and intrapleural therapy group

Drainage with pigtail and Intrapleural therapy

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

Locations (3)

Aarhus University Hospital

Aarhus, Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark