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
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865417301023
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author 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
author_facet 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
author_sort Chul Hwan Park
collection DOAJ
description 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.
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spelling doaj.art-bb4b7b7279704be4ac63de9c886a2a192022-12-21T18:52:20ZengElsevierContemporary Clinical Trials Communications2451-86542018-03-019C606310.1016/j.conctc.2017.12.001LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and RationaleChul Hwan Park0Dong Jin Im1Sang Min Lee2Ji Won Lee3Sung Ho Hwang4Semin Chong5Min Jae Cha6Kye Ho Lee7Woocheol Kwon8Hwan Seok Yong9Jae Wook Lee10Gong Yong Jin11Sang Hyun Paik12Kyunghwa Han13Jin Hur14Department of Radiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of KoreaDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of KoreaDepartment of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of KoreaDepartment of Radiology, Pusan National University Hospital, Pusan National University School of Medicine and Medical Research Institute, Busan, Republic of KoreaDepartment of Radiology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of KoreaDepartment of Radiology, Chung-Ang University Medical Center, Chung-Ang University College of Medicine, Seoul, Republic of KoreaDepartment of Radiology, Chung-Ang University Medical Center, Chung-Ang University College of Medicine, Seoul, Republic of KoreaDepartment of Radiology, Dankook University Hospital, Cheonan, Chungnam Province, Republic of KoreaDepartment of Radiology, Wonju Severance Christian Hospital, Wonju, Republic of KoreaDepartment of Radiology, Korea University Guro Hospital, Korea University College of Medicine, 80 Guro-dong, Guro-gu, Seoul, 152-703, Republic of KoreaDepartment of Radiology, Korea University Guro Hospital, Korea University College of Medicine, 80 Guro-dong, Guro-gu, Seoul, 152-703, Republic of KoreaDepartments of Radiology, Chonbuk National University Medical School and Hospital, Jeonju, Republic of KoreaDepartment of Radiology, Soonchunhyang University College of Medicine, Bucheon Hospital, Bucheon, Republic of KoreaDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of KoreaDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of KoreaBackground 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.http://www.sciencedirect.com/science/article/pii/S2451865417301023Ground-glass opacity (GGO)LocalizationLipiodolHook-wireVideo-assisted thoracic surgery (VATS)
spellingShingle 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
LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and Rationale
Contemporary Clinical Trials Communications
Ground-glass opacity (GGO)
Localization
Lipiodol
Hook-wire
Video-assisted thoracic surgery (VATS)
title LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and Rationale
title_full LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and Rationale
title_fullStr LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and Rationale
title_full_unstemmed LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and Rationale
title_short LOGIS (LOcalization of Ground-glass-opacity and pulmonary lesions for mInimal Surgery) registry: Design and Rationale
title_sort logis localization of ground glass opacity and pulmonary lesions for minimal surgery registry design and rationale
topic Ground-glass opacity (GGO)
Localization
Lipiodol
Hook-wire
Video-assisted thoracic surgery (VATS)
url http://www.sciencedirect.com/science/article/pii/S2451865417301023
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