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

21 juillet 2026 mis à jour par: National Taiwan University Hospital

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Dispositif: NTU OpVerse surgical simulation platform

Type d'étude

Observationnel

Inscription (Estimé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Chiu Hao Hsu
Numéro de téléphone: 73234 88623123456
E-mail: newmanhsu0814@gmail.com

Lieux d'étude

Taïwan
- - Taipei, Taïwan
    - Recrutement
    - National Taiwan University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population will include adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion who are scheduled to undergo extracranial-intracranial bypass surgery. Eligible procedures include STA-MCA bypass, STA trunk-graft-MCA bypass, and other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery as the donor vessel. Patients requiring emergency surgery, those with contraindications to CT imaging, severe systemic illness precluding follow-up assessment, scalp conditions or anatomical deformities preventing surface registration, or unreliable XR registration that may compromise surgical safety will be excluded.

La description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Accuracy of XR-Assisted Superficial Temporal Artery Localization Délai: During preoperative surgical planning and intraoperative confirmation on the day of surgery.	Accuracy will be assessed as the absolute distance, measured in millimeters, between the superficial temporal artery location marked using the XR-assisted surgical planning system and the actual superficial temporal artery location identified by vascular ultrasonography. The mean absolute distance error across participants will be reported.	During preoperative surgical planning and intraoperative confirmation on the day of surgery.
Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction Délai: From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery.	Accuracy will be assessed as the absolute distance, measured in millimeters, between the anastomosis site predicted using the XR-assisted surgical planning system and the actual recipient-vessel anastomosis site selected intraoperatively. The mean absolute distance error across participants will be reported.	From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery.

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
XR-Assisted STA Localization Time Délai: During preoperative preparation on the day of surgery.	The time required to localize and mark the superficial temporal artery and middle cerebral artery using the XR-assisted system will be measured in minutes, from initiation of XR registration and localization to completion of skin marking.	During preoperative preparation on the day of surgery.
Time From Skin Incision to Identification of the Recipient Vessel Délai: During the surgical procedure on the day of surgery.	The time from the initial skin incision to intraoperative identification of the middle cerebral artery recipient vessel selected for bypass will be measured in minutes.	During the surgical procedure on the day of surgery.
Total Operative Time Délai: During the surgical procedure on the day of surgery.	Total operative time will be measured in minutes, from the initial skin incision to completion of skin closure.	During the surgical procedure on the day of surgery.
Skin-Incision Length Délai: At completion of skin closure on the day of surgery.	The length of the final skin incision will be measured in centimeters after completion of the surgical procedure.	At completion of skin closure on the day of surgery.
Maximum Craniotomy Diameter Délai: During the surgical procedure on the day of surgery.	The maximum diameter of the completed craniotomy will be measured in centimeters intraoperatively.	During the surgical procedure on the day of surgery.
Intraoperative Enlargement of the Planned Craniotomy Délai: During the surgical procedure on the day of surgery.	The number and percentage of participants requiring intraoperative enlargement of the craniotomy beyond the preoperatively planned dimensions will be reported.	During the surgical procedure on the day of surgery.
Intraoperative Bypass Blood Flow Délai: Immediately after completion of the bypass anastomosis on the day of surgery.	Blood flow through the completed bypass will be measured in milliliters per minute using an intraoperative flow-measurement device after completion of the anastomosis.	Immediately after completion of the bypass anastomosis on the day of surgery.
Postoperative Ischemic Complications Délai: From completion of surgery through 30 days after surgery.	The number and percentage of participants experiencing a new postoperative cerebral ischemic event, including transient ischemic attack or ischemic stroke, will be reported. Events will be determined by neurological assessment and clinically indicated neuroimaging.	From completion of surgery through 30 days after surgery.
Postoperative Hemorrhagic Complications Délai: From completion of surgery through 30 days after surgery.	The number and percentage of participants experiencing a new postoperative intracranial hemorrhagic complication will be reported. Events will be determined by neurological assessment and postoperative neuroimaging	From completion of surgery through 30 days after surgery.
Change in Modified Rankin Scale Score Délai: From baseline before surgery to 30 days after surgery.	The change in modified Rankin Scale score will be calculated as the postoperative score minus the preoperative baseline score. The modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability.	From baseline before surgery to 30 days after surgery.
Length of Intensive Care Unit Stay Délai: From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.	The duration of postoperative intensive care unit stay will be measured in days, from admission to the intensive care unit after surgery to transfer out of the intensive care unit.	From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.
Total Length of Hospital Stay Délai: From the date of surgery through hospital discharge, up to 30 days after surgery.	The total postoperative hospital stay will be measured in days, from the date of surgery to the date of hospital discharge.	From the date of surgery through hospital discharge, up to 30 days after surgery.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Taiwan University Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 juin 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

14 juillet 2026

Première soumission répondant aux critères de contrôle qualité