Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thoraco-abdomino-pelvic CT scan without and with contrast injection..
- Who it may be relevant to
- Registry conditions: Lung Cancer, Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To assess the RELIABILITY in terms of accuracy of 3D-CT and 2D-CT reconstructions compared to intraoperative data regarding bronchovascular anatomy and tumor location. 3D CT reconstruction (CT scan without contrast injection) with Innersight3D® is equivalent to 2D CT (CT scan with contrast injection) for planning a minimally invasive lung segmentectomy. Evaluate the impact of 3D reconstruction (from a CT scan without injection of contrast agent) on intraoperative and postoperative results
Interventions
- Diagnostic test Thoraco-abdomino-pelvic CT scan without and with contrast injection.
Eligible patients undergo the usual preoperative procedure, including consultations and CT scan with and without contrast injection.
Primary outcome measures
- RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 1 [Time frame: Immediately after surgery]
- RELIABILITY of 3D-CT and 2D-CT reconstructions regarding bronchovascular anatomy and tumor location - composite 2 [Time frame: Immediately after surgery]
Eligibility criteria
Inclusion criteria
- Adult patient ≥ 18 years
- Patient agreeing to participate in the study
- Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy.
- Chest CT scan available without and then with contrast
- Eligible for VATS or RATS segmentectomy based on respiratory explorations
Exclusion criteria
- Patient refusal to participate in the study
- Allergic reactions to radiographic contrast agents
- History of ipsilateral cardiothoracic surgery
- Open segmentectomy (thoracotomy)
- Histology different from that of NSCLC
- Inability to provide the subject with informed information (difficulty understanding the subject, insufficient command of French, etc.)
- Pregnant or breastfeeding women
- Severe cognitive impairment and/or suspicion of lack of compliance or adherence, in the investigator's judgment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Service Chirurgie Thoracique - CHU de Strasbourg - France — Strasbourg
Identifiers
NCT: NCT07234604 · 9776