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

the LOGIS investigators

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)60-63
Number of pages4
JournalContemporary Clinical Trials Communications
Volume9
DOIs
Publication statusPublished - 2018 Mar 1

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Glass
Registries
Video-Assisted Thoracic Surgery
Lung
Ethiodized Oil
Safety
Recurrence
Thoracoscopy
Mortality
General Anesthesia
Multicenter Studies
Cohort Studies
Tomography
Databases
Incidence

Keywords

  • Ground-glass opacity (GGO)
  • Hook-wire
  • Lipiodol
  • Localization
  • Video-assisted thoracic surgery (VATS)

ASJC Scopus subject areas

  • Pharmacology

Cite this

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

In: Contemporary Clinical Trials Communications, Vol. 9, 01.03.2018, p. 60-63.

Research output: Contribution to journalArticle

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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.",
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T2 - Design and Rationale

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

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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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