NCT04227444|Unknown
Preoperative Evaluation of Pulmonary Vascular Anatomy by Holograms
Holo-lungs
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Holo-lungs
Sponsor study identifier
observational
50
1 country
2
Study Start
March 1, 2020
Actual (reported)Primary Completion
March 1, 2022
Actual (reported)Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pulmonary vascular anatomy represents a constant challenge during lung resection, because of its variability in terms of vascular branches and anatomical variations. Preoperative standard computed tomography is not always sufficient to foresee tricky abnormalities; augmented reality, thanks to holograms creation, may offer additional data on pulmonary vascular anatomy and its relation with neoplastic tissue. The aim of this study is to assess the possibility of correctly predict number, location and potential anomalies of pulmonary vascular anatomy of the lobe to be resected in patients undergoing lung resection for cancer. Patients will receive standard preoperative oncologic and functional assessment. Preoperative computed tomography (CT) - performed according to a specific protocol - will be performed. CT images will be subsequently elaborated to generate 3D images (holograms). Two radiologists and two thoracic surgeons will analyze CT images and report number of artery and vein branches for the lobe to be resected. Moreover they will report every anatomical variation, according to the normal anatomy. After that, the same two radiologists and thoracic surgeons will analyze the holograms and perform the same analysis as quoted above. Patients will undergo to the planned surgical resection. The operating team will report the exact number of artery and vein branches of the resected lobe as well as every anatomical variation. Preoperative CT and holographic findings of the radiologists and the thoracic surgeons will be matched with the report of the operating team.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2020
Actual (reported)January 13, 2020
Actual (reported)March 1, 2020
Actual (reported)March 1, 2022
Actual (reported)March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prediction of the exact number of pulmonary arteries and veins of the lobe to be resected.
Two different investigator (1 senior radiologist and 1 senior thoracic surgery) evaluate standard preoperative CT scan and indicate the number of pulmonary artery and veins of the lobe to be resected; this will be reported in a dedicated registry. After that, the same investigators will evaluate holograms of the same patients and will report the number of arteries and veins of the lobe to be resected; they will then register these data in the same registry. After the operation, the operating surgeon will report - as usual - the number of the arteries and veins resected during the procedure. Finally the prediction of the investigators obtained only by CT scan evaluation or bay CT scan + holograms evaluation, will be compared with the operatory report.
2020 - 2022
Patient undergoing elective anatomical resection for lung cancer will receive standard preoperative CT scan of the chest (as usual); CT images will be subsequently elaborated by a Holographic computer to generate 3D images (holograms).Two radiologists and two thoracic surgeons will analyze CT images in a standard modality and report number of artery and vein branches for the lobe to be resected, moreover they will report every anatomical variation, according to the normal anatomy. After that, the same two radiologists and thoracic surgeons will analyze 3D images by the use of Microsoft Hololens and perform the same analysis as quoted above. For each review of the exam performed will be written a digitally signed clinical report to certify the timing of the evaluation and to be able to trace the analysis and any subsequent modifications of the interpretation of the CT images results.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients suffering from (any) lung cancer scheduled for anatomical lung resection
European Institute of Oncology
Milan, 20141, Italy
European Institue of Oncology
Milan, 20143, Italy
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First Submitted
January 7, 2020
First Posted
January 13, 2020
Study Start
March 1, 2020
Actual (reported)Primary Completion
March 1, 2022
Actual (reported)Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
Contact the study team to confirm eligibility.
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Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 28, 2023
Record last verified: 2023-06
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