Dataset Information

Study protocol for DICE trial: Video-assisted thoracoscopic surgery decortication versus interventional radiology guided chest tube insertion for the management of empyema.

ABSTRACT:

Background

Empyema is a common thoracic surgery presentation, defined as pus in the pleural space. Despite the commonality of empyema, consensus on initial management remains ambiguous. Two standard of care treatment options include inserting a chest tube (thoracostomy) and the administration of intrapleural fibrinolytics, or an initial surgical approach, surgical decortication. Due to the complexity of this pleural space infection, often repeat interventions are required after initial management in order to achieve source control and resolution of clinical symptoms. This study aims to identify the most effective initial management option for empyema.

Study design

We present a study protocol for a randomized control trial (RCT) comparing adult individuals with empyema to one of two standard of care initial management options. Participants will be randomized into either interventional radiology guided chest tube insertion with intrapleural fibrinolytics (Dornase 5 mg and Alteplase 10 mg intrapleural twice daily for three days) or video-assisted thoracoscopic surgery (VATS) decortication.

Methods

All adults with empyema meeting inclusion criteria will be invited to participate. They will be randomized into one of two intervention groups; interventional radiology guided chest tube insertion with fibrinolytics or initial VATS decortication. Each intervention will take place within 48 hours of randomization. The primary outcome will be the rate of re-intervention within 30 days. Re-intervention is defined as repeat chest tube insertion, VATS decortication, or decortication via thoracotomy. Secondary outcomes include a change in the size of empyema, length of stay, morbidity, as well as 30-day and 90-day mortality, as well as quality of life measurements.

Anticipated impact

This study is aimed at identifying the most effective initial management option for individuals with empyema.

SUBMITTER: Williams E

PROVIDER: S-EPMC8105624 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Management of empyema has been debated in the literature for decades. Although both primary video-assisted thoracoscopic surgery (VATS) and tube thoracostomy with pleural instillation of fibrinolytics have been shown to result in early resolution when compared to tube thoracostomy alone, there is a lack of comparative data between these modes of management. Therefore, we conducted a prospective, randomized trial comparing VATS to fibrinolytic therapy in children with empyema.After Institutional Review Board approval, children defined as having empyema by either loculation on imaging or more than 10,000 white blood cells/microL were treated with VATS or fibrinolysis. Based on our retrospective data using length of postoperative hospitalization as the primary end point, a sample size of 36 patients was calculated for an alpha of .5 and a power of 0.8. Fibrinolysis consisted of inserting a 12F chest tube followed by infusion of 4 mg tissue plasminogen activator mixed with 40 mL of normal saline at the time of tube placement followed by 2 subsequent doses 24 hours apart.At diagnosis, there were no differences between groups in age, weight, degree of oxygen support, white blood cell count, or days of symptoms. The outcome data showed no difference in days of hospitalization after intervention, days of oxygen requirement, days until afebrile, or analgesic requirements. Video-assisted thoracoscopic surgery was associated with significantly higher charges. Three patients (16.6%) in the fibrinolysis group subsequently required VATS for definitive therapy. Two patients in the VATS group required ventilator support after therapy, one of whom required temporary dialysis. No patient in the fibrinolysis group clinically worsened after initiation of therapy.There are no therapeutic or recovery advantages between VATS and fibrinolysis for the treatment of empyema; however, VATS resulted in significantly greater charges. Fibrinolysis may pose less risk of acute clinical deterioration and should be the first-line therapy for children with empyema.

Project description:BackgroundPrevious studies of decortication for empyema demonstrated that patient characteristics are associated with mortality, but the relationship of infectious pathogen to outcome has not been described. Our objective was to analyze the association of microbiology and antibiotic resistance with postoperative mortality after decortication for empyema. We hypothesized that bacterial pathogens, antibiotic resistance, and patient characteristics would all contribute to perioperative morbidity and mortality.MethodsPatients undergoing pulmonary decortication for empyema from January 1, 2010 to October 1, 2017 were reviewed retrospectively. Cases were matched with microbiology cultures. Outcomes of interest were a composite of death, tracheostomy, initial ventilator support greater than 48 hours, or unexpected intensive care unit readmission. Antibiotic resistance was categorized as present or absent, and the number of antibiotics with resistance was counted for each patient. We describe the relationship of patient characteristics, antibiotic resistance, and microbiology to mortality.ResultsDuring the study period, 185 patients underwent decortication, 118 of whom had a diagnosis of primary empyema (63.8%). Positive culture results were present in 79 of 185 patients (43%). The most common isolate was Streptococcus, which was present in 29 of 79 (37%), followed by Staphylococcus in 19 of 79 (24%). Of 79 patients, 11 had fungal infections (13.9%). In addition, 16 of 79 patients had polymicrobial empyema (20%). Of 185 patients, 30 experienced the composite adverse outcome (16.2%). In multivariable regression, the composite adverse outcome was associated with emphysema, Candida in pleural culture, and antibiotic resistance count.ConclusionsPerioperative mortality and morbidity after decortication for empyema is considerable. In this cohort, infections with increasing antibiotic resistance are associated with morbidity and mortality among patients with empyema.