Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery

Study Overview
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Brief Summary
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In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.

Detailed Description
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The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop a new procedure for intraoperative localization of pulmonary nodules in video-assisted thoracoscopic surgery.

Official Title
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Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery

Conditions
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Thoracoscopy

Intervention / Treatment
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* Procedure: CBCT acquisition
* Procedure: Anesthesia and surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18; patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm; Complete preoperative assessment; Patient receiving information about the protocol who did not indicate his/her opposition to participate; Patient covered by a social insurance system Exclusion Criteria: Reoperation (history of ipsilateral thoracic surgery); Inability to achieve or obtain a single-lung ventilation during surgery; Adult subject to legal protection (trusteeship, guardianship); Person deprived of liberty.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBCT Acquisition<br>The anesthesia and surgery will take place in the usual way. The intervention consists in the CBCT acquisition after the initiation of single-lung ventilation, after the introduction of trocars. | Procedure: CBCT acquisition<br>* Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device<br>* Other names: Artis Zeego System®;Procedure: Anesthesia and surgery<br>* The anesthesia and surgery will take place according clinical routine practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of CBCT | Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons. | the day following the acquisition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of CBCT | Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason. | At the end of the surgery | 
| Assessment of global image quality | Assessment of image quality is based on an open label interpretation of CBCT images by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images) | the day following the acquisition | 
| Assessment of image quality of lesions | Assessment of image quality depending on the type of lesion and their location. Interpretation of CBCT images are performed by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images) | the day following the acquisition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video assisted thoracoscopy, Cone beam computed tomography