Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01353-48 | Other Identifier | Id-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBCT Acquisition | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBCT acquisition | Procedure | Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simon ROUZE, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de RENNES | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33588119 | Result | Alvarez P, Rouze S, Miga MI, Payan Y, Dillenseger JL, Chabanas M. A hybrid, image-based and biomechanics-based registration approach to markerless intraoperative nodule localization during video-assisted thoracoscopic surgery. Med Image Anal. 2021 Apr;69:101983. doi: 10.1016/j.media.2021.101983. Epub 2021 Jan 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Anesthesia and surgery | Procedure | The anesthesia and surgery will take place according clinical routine practice |
|
| 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 |