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

Thoracoscopy Clinical Trial

— CAVIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966847
• Other study ID #: 35RC16_9838
• Secondary ID: 2016-A01353-48
• Status: Completed
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: March 22, 2019

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thoracoscopy

Intervention

Procedure:
• CBCT acquisition
Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device
• Anesthesia and surgery
The anesthesia and surgery will take place according clinical routine practice

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de RENNES	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of CBCT	Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason.	At the end of the surgery
Secondary	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
Secondary	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