Abstract
BackgroundLocalization of small and/or deep pulmonary nodules before thoracoscopic exploration is paramount to minimize the likelihood of unplanned conversion to thoracotomy. As far as the percutaneous approach is concerned, the most common workflow consists of preoperative computed tomography (POCT) imaging-guided tumor marking (performed in an interventional CT suite) followed by their removal in an operating room (OR). However, the advent of hybrid ORs has allowed intraoperative computed tomography (IOCT)-guided lesion localization. This single center, open-label, randomized, controlled clinical trial aims to compare the efficacy and safety of IOCT versus POCT.Methods/designThe study sample will consist of patients presenting with small and/or deep pulmonary nodules who will be randomly allocated to either POCT or IOCT. The time required to complete lesion localization will be the primary efficacy outcome. The following parameters will serve as secondary endpoints: rate of successful targeting during localization and in the operating field, time at risk, operating time, length of time under anesthesia, global OR utilization time, complication (pneumothorax and hemorrhage) rates, and radiation exposure.DiscussionOwing to the increased availability of HORs, our data will be crucial to clarify the feasibility and safety of IOCT versus the traditional POCT approach.Trial registrationClinicalTrials.gov, NCT03395964. Registered on October 8, 2018.
Highlights
Localization of small and/or deep pulmonary nodules before thoracoscopic exploration is paramount to minimize the likelihood of unplanned conversion to thoracotomy
Numerous studies have already shown that intraoperative computed tomography (IOCT) is clinically feasible [14,15,16], the question as to whether this approach is superior to traditional preoperative computed tomography (POCT) remains open [17]
Currently, two major techniques can be implemented for performing computed tomography (CT)-guided video-assisted thoracoscopic surgery (VATS) removal of pulmonary nodules
Summary
Two major techniques can be implemented for performing CT-guided VATS removal of pulmonary nodules. All authors contributed to the methodological design of the trial, as well as to data analysis and manuscript writing. The funding bodies have no role in study design, data collection, analysis and interpretation, and writing of the manuscript. Ethics approval and consent to participate The study was granted ethics approval by the Institutional Review Board of the Chang Gung Memorial Hospital on October 1, 2016 (CGMHIRB: 201600671A3). Author details 1Division of Thoracic Surgery Chang Gung Memorial Hospital-Linko, College of Medicine Chang Gung University, Taoyuan, Taiwan. Author details 1Division of Thoracic Surgery Chang Gung Memorial Hospital-Linko, College of Medicine Chang Gung University, Taoyuan, Taiwan. 2Department of Medical Imaging and Intervention College of Medicine, Chang Gung University, Taoyuan, Taiwan
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