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

Not Applicable

Completed

• Conditions: Thoracoscopy
• Interventions: Procedure: CBCT acquisition; Procedure: Anesthesia and surgery

• Registration Number: NCT02966847
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Study Start: 2017-05-11
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBCT Acquisition	CBCT acquisition	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.
CBCT Acquisition	Anesthesia and surgery	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de RENNES; 🇫🇷 Rennes, France