Protocol for the VAL-MAP 2.0 trial: a multicentre, single-arm, phase III trial to evaluate the effectiveness of virtual-assisted lung mapping by bronchoscopic dye injection and microcoil implementation in patients with small pulmonary nodules in Japan

Abstract

IntroductionTumour localisation is important for successful resection of lung nodules with optimal resection margins in sublobar resection. Virtual-assisted bronchoscopic localisation technique combined with dye marking and microcoil placement (VAL-MAP 2.0) is a minimally invasive, virtual-assisted, bronchoscopic technique that combines dye marking and microcoil implementation. As indwelling microcoils can provide information on the depth from the lung surface, they can be applied for deeply located small lung tumours that are barely identifiable by surface dye marking. This proposed study will examine the effectiveness of VAL-MAP 2.0 in patients with small pulmonary nodules.Methods and analysisThis is a multicentre, prospective, single-arm, clinical trial. A total of 65 patients will be registered to undergo VAL-MAP 2.0 followed by thoracoscopic surgery. The primary outcome is successful resection, defined as resection of the lesion with optimal resection margins. The goal of the study is the achievement of a successful resection rate of 80%.Ethics and disseminationThe study was approved by the Clinical Research Review Boards of the University of Tokyo (approval number 218 003SP) for all institutes, and the Technical Review Board for Advanced Medicine Category B of the Ministry of Health, Labour and Welfare. Results of the primary and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberjRCTs031180099

The role of virtual-assisted lung mapping 2.0 combining microcoils and dye marks in deep lung resection

“…The details of determining the primary goal and sample size calculation were described previously. 11 Most important, among patients in the previous study undergoing original VAL-MAP, the successful resection rate of those meeting the inclusion criteria in the present study was 78%. Assuming the superiority of VAL-MAP 2.0 over the conventional method for resecting deeply located nodules with adequate margins, a successful resection rate of 80% was considered an appropriate primary goal.…”

“…The study was approved by The University of Tokyo, Clinical Research Review Board (Approval Number 218003SP) for all institutes, and the study was preregistered in the Japan Registry of Clinical Trials (jRCTs031180099). The study protocol proposal was published previously 11 (Online Data Supplement).…”

Managing screening-detected subsolid nodules—the Asian perspective

“…However, for some deeply-seated GGNs, even twodimensional localization might not guarantee sufficient resection margins at greater depths (43), and the concept of three-dimensional localization or mapping with centrally placed fiducial markers has been raised for acquiring adequate deep margins in a standardized and reproducible manner. Therefore, a next-generation lung mapping system (VAL-MAP 2.0) has been developed (44), and a phase III prospective trial is also in progress to evaluate the effectiveness of small-nodule resections with optimal resection margins (45). Because the new technologies and modalities for localization will continue to progress, surgeons in different institutions should choose a suitable method, based on the facilities they can use, while balancing efficacy, safety, and cost.…”

Intraoperative imaging and localization techniques for part-solid nodules

“…Virtual bronchoscopy is the basis for virtual-assisted lung mapping, which involves multi-spot dye marking to create a preoperative “lung map” for the surgeon to identify lesions for sublobar resections. 15 It has been shown to have a good safety profile and high degree of accuracy with a successful resection rate of 87.7%. 15 , 16 However, for tumors more than 30 mm from the pleural surface, virtual-assisted lung mapping is less effective in achieving the necessary resection margins.…”

“… 15 It has been shown to have a good safety profile and high degree of accuracy with a successful resection rate of 87.7%. 15 , 16 However, for tumors more than 30 mm from the pleural surface, virtual-assisted lung mapping is less effective in achieving the necessary resection margins. 17 For dye marking, the most commonly used agent is methylene blue.…”