Trials. 2023 Sep 16;24(1):594. doi: 10.1186/s13063-023-07600-w.
ABSTRACT
INTRODUCTION: Pulmonary segmentectomy, when combined with hilar and mediastinal lymphadenectomy, is currently considered the gold standard treatment for early-stage lung tumors (NSCLC) smaller than 2 cm in diameter. The preoperative planning for segmentectomies usually includes a contrast-enhanced CT with 2D reconstructions (axial, coronary, and sagittal). Recent technological advances allow 3D (volume rendering) reconstructions of preoperative CT scans, intended to improve the surgeon’s understanding of the segmental anatomy. The study aims to investigate the added value of 3D reconstruction in enhancing the surgeon’s understanding of anatomical structures, thus facilitating surgical planning and improving oncological outcomes.
METHODS AND ANALYSIS: This is a prospective, randomized, controlled study. Patients will be randomized into two groups: 1. Group 2D: the preoperative workup for these patients will consist of a contrast-enhanced chest CT with two-dimensional (2D) reconstructions (axial, coronary, and sagittal); 2. Group 3D: the preoperative workup for these patients will consist of a contrast-enhanced chest CT with two-dimensional (2D) reconstructions (axial, coronary, and sagittal) and a 3D reconstruction (volume rendering) of the same chest CT employing dedicated software. The primary endpoints will be negative margin (R0) resection rate, resection margin (staple line-to-tumor distance), and thoracotomy conversions. We will use Fisher’s exact test for binary outcomes and Mann-Whitney U test for continuous outcomes. For subgroup analyses, we will use regression. Multivariable analyses will be based on logistic regression for binary outcomes and linear regression for continuous outcomes.
ETHICS AND DISSEMINATION: The protocol and the model informed consent forms have been reviewed and approved by the ethics committee (N.: 1-2023) concerning scientific content and compliance with applicable research and human subject regulations. A Subcommittee on Publications was established to review all publications and report its recommendations to the steering committee. The anonymized participant-level dataset and statistical code for generating the results will not be publicly available.
TRIAL REGISTRATION: The protocol was registered at ClinicalTrials.gov (ID: NCT05716815; Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy – Full-Text View – ClinicalTrials.gov). Jan 19, 2023.
PMID:37717001 | DOI:10.1186/s13063-023-07600-w
