Application of Extended Reality (XR)-Assisted Computed Tomography (CT)-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery

Официальное название

Application of Extended Reality (XR)-Assisted CT-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery

Обзор

This study will evaluate the application of a metaverse-based surgical simulation platform in extracranial-intracranial (EC-IC) bypass surgery. The study population will include patients with moyamoya disease or chronic cerebral ischemia who are scheduled to undergo EC-IC bypass surgery. Before surgery, preoperative brain computed tomography images will be imported into the metaverse surgical simulation platform. During surgery, extended reality technology will be used to provide precise localization of the relevant vessels, including both the donor and recipient arteries. The primary objective is to assess the localization accuracy of this platform. The study will also investigate whether this technology can facilitate a minimally invasive surgical approach and improve surgical safety.

Вмешательства

• Устройство NTU OpVerse surgical simulation platform
  NTU OpVerse is a patient-specific metaverse-based surgical simulation and assistance platform developed through collaboration among National Taiwan University Hospital, National Taiwan University, and technology partners. The platform integrates medical-image processing, three-dimensional reconstruction, digital-twin technology, and extended reality, including virtual, augmented, and mixed-reality applications. Patient-specific computed tomography or magnetic resonance imaging data can be impor

Первичные конечные точки

• Accuracy of XR-Assisted Superficial Temporal Artery Localization [Срок оценки: During preoperative surgical planning and intraoperative confirmation on the day of surgery.]
• Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction [Срок оценки: From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery.]

Вторичные конечные точки (12)

• XR-Assisted STA Localization Time [Срок оценки: During preoperative preparation on the day of surgery.]
• Time From Skin Incision to Identification of the Recipient Vessel [Срок оценки: During the surgical procedure on the day of surgery.]
• Total Operative Time [Срок оценки: During the surgical procedure on the day of surgery.]
• Skin-Incision Length [Срок оценки: At completion of skin closure on the day of surgery.]
• Maximum Craniotomy Diameter [Срок оценки: During the surgical procedure on the day of surgery.]
• Intraoperative Enlargement of the Planned Craniotomy [Срок оценки: During the surgical procedure on the day of surgery.]
• Intraoperative Bypass Blood Flow [Срок оценки: Immediately after completion of the bypass anastomosis on the day of surgery.]
• Postoperative Ischemic Complications [Срок оценки: From completion of surgery through 30 days after surgery.]
• Postoperative Hemorrhagic Complications [Срок оценки: From completion of surgery through 30 days after surgery.]
• Change in Modified Rankin Scale Score [Срок оценки: From baseline before surgery to 30 days after surgery.]
• Length of Intensive Care Unit Stay [Срок оценки: From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.]
• Total Length of Hospital Stay [Срок оценки: From the date of surgery through hospital discharge, up to 30 days after surgery.]

Критерии участия

Критерии включения

• Adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion (chronic ICA stenosis/occlusion).
• Patients scheduled to undergo extracranial-intracranial bypass surgery (EC-IC bypass), including superficial temporal artery-middle cerebral artery bypass (STA-MCA bypass), superficial temporal artery trunk-interposition graft-middle cerebral artery bypass (STA trunk-graft-MCA bypass), or other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery system (STA/ECA system) as the donor blood supply.

Критерии исключения

• Presence of a contraindication to computed tomography (CT) scanning.
• Presence of a severe systemic illness that would prevent participation in subsequent study assessments, such as poorly controlled diabetes mellitus, active malignancy, or severe cardiac disease.
• The need for emergency surgery without sufficient time to complete image-based modeling and registration.
• Presence of scalp lesions, wounds, or anatomical deformities that prevent reliable surface registration.
• The XR registration result is considered unreliable by the research team and may potentially compromise surgical safety.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Публикации

• Saemann A, de Wilde D, Guzman R, Soleman J, Greuter L. Augmented and Virtual Reality in Open Neurovascular Surgery: A Systematic Review of the Literature. World Neurosurg. 2026 Jan;205:124632. doi: 10.1016/j.wneu.2025.124632. Epub 2025 Nov 6. PMID 41205868
• Bhatia S, Huynh A, Shanahan RM, Kann MR, Gopakumar A, Sharma N, Kass NM, Hurt G, Basdeo R, Don N, Lang MJ, Biehl JT, Andrews EG. Optimizing the Workflow of Superficial Temporal Artery Mapping in Extracranial-Intracranial Bypass Surgery Using Mixed Reality: A Proof-of-Concept Study. World Neurosurg. 2025 Dec;204:124562. doi: 10.1016/j.wneu.2025.124562. Epub 2025 Oct 13. PMID 41093253

Идентификаторы

NCT: NCT07711457 · 202605074RINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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