VATS vs Intrapleural Enzymatic Therapy for Empyema in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with pneumonia-related pleural infection who fail standard chest-tube therapy are randomized to receive either video-assisted thoracoscopic surgery (VATS) or intrapleural enzymatic therapy (IET). The study aims to compare clinical outcomes such as mortality and length of hospital stay, along with costs and recovery measures. It uses a head-to-head, interventional design to determine which modality provides better control of infection and faster recovery. The trial is conducted at multiple centers led by Amsterdam UMC with collaborating hospitals. Enrollment targets adults 18 and older with biopsy-confirmed or radiologically suspected parapneumonic pleural infection after failure of initial care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years with pneumonia and suspected parapneumonic pleural infection, evidenced by (both obligatory):
* Pleural fluid which is either

  * Purulent
  * Gram stain or culture positive
  * Acidic (pH\<7.2)
  * Low in glucose (\<2 mmol/L)

AND

* Radiological suspicion of parapneumonic pleural infection (on either radiograph, ultrasound (US) or Computed Tomography-scan (CT-scan)), e.g. showing septations (US) or pleural contrast enhancement (CT)
* Fit for surgery (ie able to be ventilated on one lung during the procedure).
* Failure of standard care (consisting of a chest tube and antibiotics) as judged by the treating physician ≤ 24 h after chest tube insertion, considering: Radiology (significant residual pleural collections on imaging); Insufficient decrease of inflammatory markers (C-reactive protein (CRP) and white blood cell (WBC)); Clinical status of the patient (lack of improvement).
* Able to provide informed consent.

Exclusion Criteria:

* Patients not fit for surgery.
* Patients requiring direct surgery (e.g. dry tap). These are patients in which a non-surgical approach is considered to be not successful from the start. This decision will be made by combining the clinical status of the patient and the findings of the additional (radiological) investigations.
* Patients with a suspected or confirmed bronchopleural fistula.
* Need for more than two chest tubes at presentation.
* Any contraindication to IET (bleeding risk, allergy).
* A parapneumonic pleural infection with another cause than a pneumonia (e.g. infection after an intervention or after pulmonary/esophageal surgery, but also pneumonia related to obstruction due to lung cancer).
* Previous treatment of a parapneumonic pleural infection \<1 year ago, a history of pulmonary surgery on the same side of the parapneumonic pleural infection.
* Life expectancy \<3 months and/or suffer from a terminal illness.
* Patients who are pregnant or lactating (pregnancy status will be confirmed prior to randomisation for woman of childbearing potential).

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Wilja de Jonge, MD
• Email: w.r.dejonge@amsterdamumc.nl
• Phone: +31650063948

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Early Pleural Irrigation with Saline vs Standard Care for Complicated Pleural Infections

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• Flushing chest drains to improve outcomes in pleural infections

  This study is testing if flushing chest drains with saline every six hours can help people with serious lung infections recover faster and spend less time in the hospital.

  Recruiting at 5 sites Vanderbilt University Medical Center · Sterling Heights, Michigan and 4 other locations · NCT06427538

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.