Labelling of subpleural pulmonary nodules with blue dye and contrast agents under CT-guided control and subsequent video-assisted thoracoscopic resection: the BLUEPAT prospective randomised study

BACKGROUND: Colour marking of indicated nodules is an innovative, accurate, and gentle method that allows subsequent wedge resection of the marked tissue using a mini-invasive, video-assisted thoracoscopic (VATS) method with all its benefits. One of the expected benefits of this clinical trial is introducing and optimising the evaluated way into routine management in diagnosing and treating focal lung diseases. The BLUEPAT clinical trial aims to assess the technique of colour marking of subpleural deposited small lung nodules with the subsequent performance of VATS wedge resection in surgical practice. METHODS: The BLUEPAT clinical trial is a prospective, monocentric, open-label, randomised study that will include 72 participants with subpleural deposited nodules with the need for additional histological diagnostics to optimise subsequent treatment. These patients will be randomised into two arms in a 1:1 ratio. The interventional arm will undergo VATS wedge resection of lung nodules marked with Patent Blue V and contrast agent iohexol under CT-guided control. The control arm will undergo VATS resection without prior colour coding of the lung nodules. The feasibility and safety of both methods will be assessed based on the evaluation of the parameters of the primary and secondary objectives of the study. The safety of the methods will be monitored by recording all related adverse events. All enrolled patients will undergo a 30-day follow-up period within the framework of clinical trial. RESULTS: This article reports the clinical trial protocol; outcome data will be published upon study completion. DISCUSSION: The BLUEPAT clinical trial offers a novel assessment of this innovative approach for the diagnosis and treatment of focal lung diseases. The use of patent blue dye has been well established in diagnostic procedures for breast cancer and this study extends its potential application to pulmonary indications. TRIAL REGISTRATION: EudraCT Number 2021-001122-22. Registered on March 18, 2021.