Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lung Cancer, Lung; Node

Intervention / Treatment
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* Diagnostic Test: CT scans 2D Reconstruction
* Diagnostic Test: CT scans 2D plus 3D Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Segmentectomy performed through a minimally invasive approach (VATS or RATS). Pathologically proven NSCLC on the resected specimen. Age ≥18 Signed written informed consent Exclusion Criteria: Prior homolateral cardiothoracic surgery. Allergy or any other contraindication to iodinated contrast media. Segmentectomy performed through an open approach (thoracotomy) Histology different than NSCLC. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective multicenter randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D Reconstruction<br>Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with multi-plane (2D) reconstructions, according to the usual center protocol. | Diagnostic Test: CT scans 2D Reconstruction<br>* 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.<br>|
| Experimental: 2D plus 3D Reconstruction<br>Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with volume rendering (3D) reconstructions. | Diagnostic Test: CT scans 2D plus 3D Reconstruction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversions from minimally invasive to thoracotomic procedure | Evaluation of conversions from minimally invasive to thoracotomic procedure | Intraoperative | 
| Margin- and disease-free resection | Margin- and disease-free resection | 1 Month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating times | Evaluation of operating times | Intraoperative | 
| Intraoperative blood loss | Evaluation of intraoperative blood loss | Intraoperative | 
| Intraoperative major bleeding | Intraoperative major bleeding | Intraoperative | 
| Intraoperative air leaks and the use of sealants | Evaluation of intraoperative air leaks and the use of sealants | Intraoperative | 
| Postoperative air leaks | Evaluation of postoperative air leaks | up to 2 weeks | 
| Hospitalization times | Evaluation of hospitalization times | up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Segmentectomy, CT 3D Recostruction, VATS, RATS