LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and Rationale

Background and purpose: An optimal pulmonary localization technique for video-assisted thoracic surgery (VATS) of small lung nodules has not yet been established. The LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery (LOGIS) registry aims to establish a multicenter datab...

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Main Authors: Chul Hwan Park, Dong Jin Im, Sang Min Lee, Ji Won Lee, Sung Ho Hwang, Semin Chong, Min Jae Cha, Kye Ho Lee, Woocheol Kwon, Hwan Seok Yong, Jae Wook Lee, Gong Yong Jin, Sang Hyun Paik, Kyunghwa Han, Jin Hur
Format: Article
Language:English
Published: Elsevier 2018-03-01
Series:Contemporary Clinical Trials Communications
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Online Access:http://www.sciencedirect.com/science/article/pii/S2451865417301023
Description
Summary:Background and purpose: An optimal pulmonary localization technique for video-assisted thoracic surgery (VATS) of small lung nodules has not yet been established. The LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery (LOGIS) registry aims to establish a multicenter database and investigate the usefulness and safety of localization techniques for small pulmonary lesions in individuals undergoing VATS. Methods/Design: The LOGIS registry is a large-scale, multicenter cohort study, aiming to enroll 825 patients at 10 institutions. Based on the inclusion and exclusion criteria, all study participants with pulmonary lesions indicated for VATS will be screened and enrolled at each site. All study participants will undergo preoperative lesion localization by the hook-wire or lipiodol localization methods according to site-specific methods. Within a few hours of marking, thoracoscopic surgery will be done under general anesthesia by experienced thoracoscopic surgeons. The primary endpoints are the success and complication rates of the two localization techniques. Secondary endpoints include procedure duration, recurrence rate, and all-cause mortality. Study participant enrollment will be completed within 2 years. Procedure success rates and incidence of complications will be analyzed based on computed tomography findings. Procedure duration, recurrence rate, and all-cause mortality will be compared between the two techniques. The study will require 5 years for completion, including 6 months of preparation, 3.5 years for recruitment, and 1 year of follow-up endpoint assessment. Discussion: The LOGIS registry, once complete, will provide objective comparative results regarding the usefulness and safety of the lipiodol and hook-wire localization techniques.
ISSN:2451-8654