Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy — PATCHES  

Lung Cancer Clinical Trial

Official title: Prospective Randomized Study on the Efficacy of Three-dimensional Reconstructions of Bronchial and Vascular Structures on Preoperative Chest CT Scan in Patients Who Are Candidates for Pulmonary Segmentectomy Surgery

Status Not yet recruiting

Clinical Trial Summary

With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.

Clinical Trial Description

Pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter <2 cm in diameter. Patients who are candidates for this type of treatment perform usually a preoperative CT scan with two-dimensional reconstructions (2D: axial, coronary and sagittal). Today it is possible to perform a preoperative three-dimensional reconstruction (3D: volume rendering) of the vessels and bronchi using special software.

Objectives of the study is to analyze, in these patients, the benefits of 3D reconstruction of vessels and bronchi compared to 2D reconstruction, analyzing intra- and post-operative data.The study aims to randomize 288 patients over 36 months.

Study design: Prospective, randomized, controlled study. In 50% of patients the preoperative study of anatomical structures will be performed with the standard 2D method, in the remaining 50% with a 2D and 3D reconstruction. The assignment will take place through access to an online feature on the study website.

Evaluations and statistical methods The statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (ANOVA) and covariance (ANCOVA) techniques.

Ethical aspects. The study will be conducted in accordance with applicable current legislation. Approval by all relevant ethics committees will be required. Each patient will provide a written consent to participate in the study, after being properly informed. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung; Node

• NCT number: NCT05716815
• Study type: Interventional
• Source: Ospedale Centrale Bolzano
• Contact: ZARACA Zaraca
• Phone: +393334854703
• Email: francesco.zaraca@sabes.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Completion date: May 1, 2026