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

• Published in: Contemporary clinical trials communications Vol. 9; no. C; pp. 60 - 63
• Main Authors: Park, Chul Hwan, Im, Dong Jin, Lee, Sang Min, Lee, Ji Won, Hwang, Sung Ho, Chong, Semin, Cha, Min Jae, Lee, Kye Ho, Kwon, Woocheol, Yong, Hwan Seok, Lee, Jae Wook, Jin, Gong Yong, Paik, Sang Hyun, Han, Kyunghwa, Hur, Jin
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01-03-2018; Elsevier
• Subjects: Ground-glass opacity (GGO); Hook-wire; Lipiodol; Localization; Other; Video-assisted thoracic surgery (VATS); computed tomography; Ground-glass opacity (GGO); VATS; electronic case report form; needle aspiration biopsy; video-assisted thoracic surgery; ground-glass opacity; Lipiodol; GGO; LOcalization for Ground-glass opacity and pulmonary lesions for mInimal Surgery; NAB; CT; Hook-wire; Video-assisted thoracic surgery (VATS); Localization; eCRF; LOGIS; LOGIS, LOcalization for Ground-glass opacity and pulmonary lesions for mInimal Surgery; GGO, ground-glass opacity; CT, computed tomography; eCRF, electronic case report form; NAB, needle aspiration biopsy; VATS, video-assisted thoracic surgery
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2017.12.001

Abstract 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.