Lipiodol lOcalization for Ground-glass opacity mInimal Surgery: Rationale and design of the LOGIS trial

Abstract

OBJECTIVES: The diagnosis and treatment of ground-glass opacity (GGO) lesions have become important issues because subsolid nodules including GGO are known to frequently represent the histologic spectrum of lung adenocarcinoma. Because small GGO lesions cannot usually be palpated or visualized during surgery, several marking techniques have been reported for localization during thoracoscopic surgery, such as lipiodol and hook-wire localization. This study is designed to demonstrate the usefulness and safety of the lipiodol localization technique for individuals undergoing GGO VATS resection compared to the hook-wire localization technique.

METHODS: Two hundred fifty participants will be prospectively enrolled in a 1:1 manner to the lipiodol or hook-wire group according to the inclusion criteria. All study participants will undergo preoperative lung localization using either the lipiodol or hook-wire method. Thoracoscopic surgery will be performed by experienced thoracoscopic surgeons within several hours after marking under general anesthesia. The primary endpoint is the procedure success rate, and the secondary endpoints are the procedure complication rate, procedure time, surgery time and the margin from the lesion in the resected specimen.

RESULTS: Patient enrollment will be completed within 2years. We will analyze the procedure success rate and the presence of complications with regard to the CT results. In addition, the procedure and surgery times, and the safety margin will be also compared between the 2 techniques.

CONCLUSION: If the aims of this study are achieved, then the use of lipiodol localization technique will be widespread in the localization of non-palpable pulmonary lesions that are indicated for surgical resection. (ClinicalTrials.gov: NCT02180568).