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OpenTrials
Completed

NCT Number: NCT02966847

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

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.

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Key information

Conditions

Thoracoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de RENNES

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBCT acquisition

Procedure

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

Other names: Artis Zeego System®

Anesthesia and surgery

Procedure

The anesthesia and surgery will take place according clinical routine practice

Primary outcomes

  1. Assessment of CBCT

    Time frame: 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 outcomes

  1. Feasibility of CBCT

    Time frame: At the end of the surgery

    Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason.

  2. Assessment of global image quality

    Time frame: 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)

  3. Assessment of image quality of lesions

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: CAVIT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2016
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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