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:PurposeManagement 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.MethodsAfter 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.ResultsAt 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.ConclusionsThere 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:Background Although chest tube-omitted video-assisted thoracoscopic surgery (VATS) has been proven to be safe and efficacious, its universal application is precluded by a varying morbidity rate due to a lack of standardization. Since digital chest drainage has already shown improved accuracy and consistency in the management of postoperative air leak, we incorporated it in the strategy of intraoperative chest tube withdrawal, aiming to achieve better results. Methods We collected the clinical data of 114 consecutive patients who underwent elective uniportal VATS pulmonary wedge resection at the Shanghai Pulmonary Hospital from May 2021 to February 2022. Their chest tubes were withdrawn intraoperatively after an air-tightness test facilitated by digital drainage: the end flow rate had to be kept ≤30 mL/min for >15 s at the setting of −8 cmH2O suctioning. The recordings and patterns of the air suctioning process were documented and analyzed as potential standards of chest tube withdrawal. Results The mean age of the patients was 49.7±11.7 years. The mean size of the nodules was 1.0±0.2 cm. The location of the nodules encompassed all lobes, and 90 (78.9%) patients received preoperative localization. The postoperative morbidity and mortality rates were 7.0% and 0%, respectively. Six patients had clinically overt pneumothorax and two patients had postoperative bleeding that required intervention. All of the patients recovered on conservative treatment except for one case of pneumothorax that required additional tube thoracostomy. The median length of postoperative stay was 2 days; and the median time of suctioning, peak flow rate, and end flow rate were 126 s, 210 mL/min, and 0 mL/min, respectively. The median numeric rating scale for pain was 1 on postoperative day (POD) 1 and 0 on the day of discharge. Conclusions Chest tube-free VATS assisted by digital drainage is feasible with minimal morbidity. Its strength of quantitative air leak monitoring produces important measurements for the prediction of postoperative pneumothorax and future standardization of the procedure.

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