Preoperative Evaluation of Pulmonary Vascular Anatomy by Holograms

NCT04227444 | Unknown

• 1 other identifier: R1033/19-IEO1088
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pulmonary Disease; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Hologram DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from (any) lung cancer scheduled for anatomical lung resection

You may qualify if:

• Planned anatomical resection for lung cancer
• Signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study.
• Willingness and ability to comply with study procedures.

You may not qualify if:

• Age younger than 18 years
• Contraindications to general anesthesia
• Poor general clinical conditions ( ECOG PS \>=2)
• Patients unable to provide informed consent

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (2)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

European Institue of Oncology

Milan, 20143, Italy

RECRUITING

Related Publications (11)

• Vavra P, Roman J, Zonca P, Ihnat P, Nemec M, Kumar J, Habib N, El-Gendi A. Recent Development of Augmented Reality in Surgery: A Review. J Healthc Eng. 2017;2017:4574172. doi: 10.1155/2017/4574172. Epub 2017 Aug 21.

  PMID: 29065604 BACKGROUND

• Pessaux P, Diana M, Soler L, Piardi T, Mutter D, Marescaux J. Towards cybernetic surgery: robotic and augmented reality-assisted liver segmentectomy. Langenbecks Arch Surg. 2015 Apr;400(3):381-5. doi: 10.1007/s00423-014-1256-9. Epub 2014 Nov 13.

  PMID: 25392120 BACKGROUND

• Inoue D, Cho B, Mori M, Kikkawa Y, Amano T, Nakamizo A, Yoshimoto K, Mizoguchi M, Tomikawa M, Hong J, Hashizume M, Sasaki T. Preliminary study on the clinical application of augmented reality neuronavigation. J Neurol Surg A Cent Eur Neurosurg. 2013 Mar;74(2):71-6. doi: 10.1055/s-0032-1333415. Epub 2013 Feb 12.

  PMID: 23404553 BACKGROUND

• Pessaux P, Diana M, Soler L, Piardi T, Mutter D, Marescaux J. Robotic duodenopancreatectomy assisted with augmented reality and real-time fluorescence guidance. Surg Endosc. 2014 Aug;28(8):2493-8. doi: 10.1007/s00464-014-3465-2. Epub 2014 Mar 8.

  PMID: 24609700 BACKGROUND

• Shakur SF, Luciano CJ, Kania P, Roitberg BZ, Banerjee PP, Slavin KV, Sorenson J, Charbel FT, Alaraj A. Usefulness of a Virtual Reality Percutaneous Trigeminal Rhizotomy Simulator in Neurosurgical Training. Neurosurgery. 2015 Sep;11 Suppl 3:420-5; discussion 425. doi: 10.1227/NEU.0000000000000853.

  PMID: 26103444 BACKGROUND

• Lahanas V, Loukas C, Smailis N, Georgiou E. A novel augmented reality simulator for skills assessment in minimal invasive surgery. Surg Endosc. 2015 Aug;29(8):2224-34. doi: 10.1007/s00464-014-3930-y. Epub 2014 Oct 11.

  PMID: 25303925 BACKGROUND

• Qu M, Hou Y, Xu Y, Shen C, Zhu M, Xie L, Wang H, Zhang Y, Chai G. Precise positioning of an intraoral distractor using augmented reality in patients with hemifacial microsomia. J Craniomaxillofac Surg. 2015 Jan;43(1):106-12. doi: 10.1016/j.jcms.2014.10.019. Epub 2014 Oct 29.

  PMID: 25465484 BACKGROUND

• Muller M, Rassweiler MC, Klein J, Seitel A, Gondan M, Baumhauer M, Teber D, Rassweiler JJ, Meinzer HP, Maier-Hein L. Mobile augmented reality for computer-assisted percutaneous nephrolithotomy. Int J Comput Assist Radiol Surg. 2013 Jul;8(4):663-75. doi: 10.1007/s11548-013-0828-4. Epub 2013 Mar 23.

  PMID: 23526436 BACKGROUND

• Volonte F, Pugin F, Bucher P, Sugimoto M, Ratib O, Morel P. Augmented reality and image overlay navigation with OsiriX in laparoscopic and robotic surgery: not only a matter of fashion. J Hepatobiliary Pancreat Sci. 2011 Jul;18(4):506-9. doi: 10.1007/s00534-011-0385-6.

  PMID: 21487758 BACKGROUND

• Souzaki R, Ieiri S, Uemura M, Ohuchida K, Tomikawa M, Kinoshita Y, Koga Y, Suminoe A, Kohashi K, Oda Y, Hara T, Hashizume M, Taguchi T. An augmented reality navigation system for pediatric oncologic surgery based on preoperative CT and MRI images. J Pediatr Surg. 2013 Dec;48(12):2479-83. doi: 10.1016/j.jpedsurg.2013.08.025.

  PMID: 24314190 BACKGROUND

• Petrella F, Rizzo SMR, Rampinelli C, Casiraghi M, Bagnardi V, Frassoni S, Pozzi S, Pappalardo O, Pravettoni G, Spaggiari L. Assessment of pulmonary vascular anatomy: comparing augmented reality by holograms versus standard CT images/reconstructions using surgical findings as reference standard. Eur Radiol Exp. 2024 May 10;8(1):57. doi: 10.1186/s41747-024-00458-w.

  PMID: 38724831 DERIVED

MeSH Terms

Conditions

Lung Diseases; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Francesco Petrella, MD, PhD

CONTACT

00390294372921; francesco.petrella@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)