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Trial Title:
Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy
NCT ID:
NCT05716815
Condition:
Lung Cancer
Lung; Node
Conditions: Keywords:
Lung Segmentectomy
CT 3D Recostruction
VATS
RATS
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A prospective multicenter randomized study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CT scans 2D Reconstruction
Description:
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.
Arm group label:
2D Reconstruction
Intervention type:
Diagnostic Test
Intervention name:
CT scans 2D plus 3D Reconstruction
Description:
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.
Arm group label:
2D plus 3D Reconstruction
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2023
Completion date:
May 1, 2026
Lead sponsor:
Agency:
Ospedale Centrale Bolzano
Agency class:
Other
Collaborator:
Agency:
European Institute of Oncology
Agency class:
Other
Collaborator:
Agency:
Philipps University Marburg Medical Center
Agency class:
Other
Collaborator:
Agency:
Ernst von Bergmann Hospital
Agency class:
Other
Collaborator:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Wolfson Medical Center
Agency class:
Other
Collaborator:
Agency:
University of Belgrade
Agency class:
Other
Collaborator:
Agency:
Harvard University
Agency class:
Other
Collaborator:
Agency:
University of Salamanca
Agency class:
Other
Source:
Ospedale Centrale Bolzano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05716815
