Thoracoscopy
Conditions
Keywords
Video assisted thoracoscopy, Cone beam computed tomography
Brief summary
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
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.
Interventions
PROCEDURECBCT acquisition
Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device
PROCEDUREAnesthesia and surgery
The anesthesia and surgery will take place according clinical routine practice
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of CBCT | the day following the acquisition | Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of CBCT | At the end of the surgery | Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason. |
| Assessment of global image quality | the day following the acquisition | 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) |
| Assessment of image quality of lesions | the day following the acquisition | 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) |
Countries
France
Outcome results
None listed