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

NCT ID: NCT02966847

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2019-03-22

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.

Conditions

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Thoracoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CBCT acquisition

Intervention Type PROCEDURE

Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device

Anesthesia and surgery

Intervention Type PROCEDURE

The anesthesia and surgery will take place according clinical routine practice

Interventions

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CBCT acquisition

Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device

Intervention Type PROCEDURE

Anesthesia and surgery

The anesthesia and surgery will take place according clinical routine practice

Intervention Type PROCEDURE

Other Intervention Names

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Artis Zeego System®

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon ROUZE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

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Centre Hospitalier Universitaire de RENNES

Rennes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 33588119 (View on PubMed)

Other Identifiers

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2016-A01353-48

Identifier Type: OTHER

Identifier Source: secondary_id

35RC16_9838

Identifier Type: -

Identifier Source: org_study_id

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