Labelling of subpleural deposited pulmonary foci of blue dye and contrast agent substances under CT-guided control and their subsequent video thoracoscopic wedge resection: The BLUEPAT prospective randomized study

Abstract

Background: Colour marking of indicated deposits 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 the introduction and optimization of the evaluated method into routine management in the diagnosis and treatment of focal lung diseases. The BLUEPAT clinical trial aims to evaluate the method of colour marking of subpleural deposited small lung deposits with the subsequent performance of VATS wedge resection in surgical practice.Methods: The BLUEPAT clinical trial is a prospective, monocentric, open-label, randomized study that will include 72 subjects with subpleural deposited lesions with the need for additional histological diagnostics to optimize subsequent treatment. These patients will be randomized into 2 groups in a 1:1 ratio. The first group will undergo VATS wedge resection of lung deposits marked with patent blue and contrast agent iohexol under CT-guided control. The second group will undergo VATS resection without prior colour coding of the lung deposits. 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. The patients will participate in the clinical trial for 30 days.Discussion: The BLUEPAT clinical trial provides a unique evaluation of this innovative approach in the diagnosis and treatment of focal lung diseases. Clinical trials support the patent blue dyeing diagnostic procedures for the detection of breast cancer.Trial registration: EudraCT Number 2021-001122-22, Registered on 20.04.2021, https://www.sukl.eu/modules/evaluation/detail.php?id=51957&lang=2