Application of Extended Reality (XR)-Assisted CT-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The precision of surgical planning
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The precision of surgical planning
时间窗: During the operation
Accuracy of XR-Assisted Superficial Temporal Artery Localization
时间窗: 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.
Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction
时间窗: 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.
次要结局
- Maximum Craniotomy Diameter(During the surgical procedure on the day of surgery.)
- XR-Assisted STA Localization Time(During preoperative preparation on the day of surgery.)
- Time From Skin Incision to Identification of the Recipient Vessel(During the surgical procedure on the day of surgery.)
- Total Operative Time(During the surgical procedure on the day of surgery.)
- Skin-Incision Length(At completion of skin closure on the day of surgery.)
- Intraoperative Enlargement of the Planned Craniotomy(During the surgical procedure on the day of surgery.)
- Intraoperative Bypass Blood Flow(Immediately after completion of the bypass anastomosis on the day of surgery.)
- Postoperative Ischemic Complications(From completion of surgery through 30 days after surgery.)
- Postoperative Hemorrhagic Complications(From completion of surgery through 30 days after surgery.)
- Change in Modified Rankin Scale Score(From baseline before surgery to 30 days after surgery.)
- Length of Intensive Care Unit Stay(From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.)
- Total Length of Hospital Stay(From the date of surgery through hospital discharge, up to 30 days after surgery.)