VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema (FIVERVATS)
Pleural Empyema
About this trial
This is an interventional treatment trial for Pleural Empyema
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:
- A clinical presentation compatible with pleural infection AND
Has pleural fluid which is either:
- purulent pleural fluid or
- gram stain positive or
- culture positive or
- acidic with pH < 7.2 or
- low pleural fluid glucose (< 2 mmol/L) in the absence of accurate pH measurement or
- 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
Sites / Locations
- Aarhus University HospitalRecruiting
- Rigshospitalet
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
VATS / surgical group
Drain and intrapleural therapy group
The VATS procedure must be completed as soon as possible and no later than 48 hours after randomisation. The surgery is performed with the patient in a 90 degree sideways position, using general anesthesia. Access is obtained through one to three ports, followed by purification and possibly decortication, and insertion of one pleural drain (sizes 24 - 32F) at the end of surgery. 20 ml Marcain is used as local analgetic and applied at the incision sites or as a nerve block. In the VATS group, suction on drain (- 15 cm H20) is applied in the first day after the procedure. Operator must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be registered and approved by the steering committee.
Pigtail is applied as soon as possible and within 48 hours after randomisation. Drain placement is carried out using ULS. Operators (conductors of the procedure) must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be approved by the steering committee to conduct the procedure. A pigtail catheter (minimum 10F) is inserted. Operator determines the size of drain and whether drain placement is done with one-step or Seldinger technic. The intrapleural therapy consists of treatment with the following two drugs: intrapleural Actilyse® (alteplase) 10 mg twice daily for three days intrapleural Pulmozyme® (DNase) 5 mg twice daily for three days