NCT05716815

Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Ospedale Centrale Bolzano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer
• Lung; Node

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT scans 2D Reconstruction	Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.
DIAGNOSTIC_TEST	CT scans 2D plus 3D Reconstruction	Before performing the surgery, patient performs a chest CT scan with contrast medium and standard two-dimensional (2D) reconstructions plus a 3D reconstruction are performed to study the lesion, the anatomy of the bronchi and the pulmonary venous and arterial vessels.

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2023-02-08
• Last updated: 2023-08-29