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RECRUITING

NCT07886541

PHASE4

VATS or Intrapleural Enzymatic Therapy for Patients With Empyema.

Sponsor: Amsterdam UMC

View on ClinicalTrials.gov

Summary

A parapneumonic pleural infection is a frequently encountered and serious medical emergency with high morbidity and mortality in specific patient groups (especially in the elderly and immunocompromised). The burden of disease is high; extensive hospital stays, reduced Health-Related Quality of Life (HR-QoL) and long times to return to daily activities or to work are reported by patients and in studies. Standard care of pleural infections consists of placement of a chest tube and antibiotics. It is estimated that approximately 50% of patients with a pleural infection can be treated successfully with this strategy. When standard care fails, two main treatment modalities are available. One is intrapleural enzymatic therapy (IET), where medication is inserted through the chest tube. The other modality is minimally invasive surgery by video-assisted thoracoscopic surgery (VATS). Although both modalities are extensively used, no consensus exits on which modality is superior or more cost-effective. This has led to extensive practice variation throughout hospitals in the Netherlands and to prolonged treatment episodes. The scarce literature on the subject to date appears to favor VATS in terms of treatment duration, but this is not supported by solid scientific evidence. The primary objective is to provide decisive evidence on which treatment modality is superior for the treatment of pleural infections. This evidence will help to guide future treatment decisions and will lead to optimal and cost effective treatment of pleural infections. In order to provide this evidence, the investigators aim to investigate which modality results in the shortest length of hospital stay (LOS). In addition, the investigators want to investigate which modality is superior in terms of patient-reported outcomes (PROMs), complications, re-interventions and mortality. The main trial endpoint is LOS during the first 30 days. This is defined as the time from the moment of chest tube insertion to the date of discharge.

Official title: VATS or Intrapleural Enzymatic Therapy for patientS With Empyema (the VIETS Trial).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2026-10

Completion Date

2029-10

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Empyema, Pleural Pleural Infections

Interventions

PROCEDURE

VATS group

VATS procedure to remove the infected fluid and facilitate re-expansion of the infected lung.

DRUG

IET

Intrapleural Enzymatic Therapy Consisiting of Alteplase 10mg and DNase 5mg

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).

Locations (1)

Amsterdam UMC

Amsterdam, Netherlands