TY - JOUR
T1 - LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry
T2 - Design and Rationale
AU - on behalf of
AU - the LOGIS investigators
AU - Park, Chul Hwan
AU - Im, Dong Jin
AU - Lee, Sang Min
AU - Lee, Ji Won
AU - Hwang, Sung Ho
AU - Chong, Semin
AU - Cha, Min Jae
AU - Lee, Kye Ho
AU - Kwon, Woocheol
AU - Yong, Hwan Seok
AU - Lee, Jae Wook
AU - Jin, Gong Yong
AU - Paik, Sang Hyun
AU - Han, Kyunghwa
AU - Hur, Jin
N1 - Publisher Copyright:
© 2017 The Authors
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2018/3
Y1 - 2018/3
N2 - 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.
AB - 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.
KW - Ground-glass opacity (GGO)
KW - Hook-wire
KW - Lipiodol
KW - Localization
KW - Video-assisted thoracic surgery (VATS)
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U2 - 10.1016/j.conctc.2017.12.001
DO - 10.1016/j.conctc.2017.12.001
M3 - Article
AN - SCOPUS:85037822447
VL - 9
SP - 60
EP - 63
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
SN - 2451-8654
ER -