Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial

BACKGROUND: Localization 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/DESIGN: The 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. DISCUSSION: Owing 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 REGISTRATION: ClinicalTrials.gov, NCT03395964. Registered on October 8, 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3532-z) contains supplementary material, which is available to authorized users.