Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 15
- 主要终点
- Survival rate
研究概览
简要总结
The purpose of this clinical trial is to observe the improvements in clinical symptoms and imaging outcomes for brainstem hemorrhage using robot-assisted stereotactic puncture, evaluate the clinical efficacy and safety of this treatment, and explore the development of a high-precision, intelligent, and individualized microsurgical diagnosis and treatment process for brainstem hemorrhage. The main questions it aims to address are:
- Establish a multi-center clinical database for brainstem hemorrhage.
- Clinically observe and evaluate the intervention effects of robot-assisted stereotactic puncture on brainstem hemorrhage, compare it with the traditional conservative treatment control group, and investigate its efficacy and impact on patient survival, motor evoked potentials, and the degree of neurological deficits.
- Optimize the Artificial Intelligence (AI) algorithm-based robotic surgical assistance system, and explore the prediction of preoperative brainstem hematoma stability and hematoma path planning.
Participants in the experimental group will:
- Undergo robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture
- Receive conservative non-surgical treatment.
If there is a control group: the researchers will compare the conservative non-surgical treatment group to evaluate the effectiveness of robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at randomization；
- •Diagnosed with brainstem hemorrhage via imaging (CT, CTA, etc.)；
- •Hematoma volume ≥3 mL；
- •Glasgow Coma Scale (GCS) score of 3-12；
- •Available for surgery within 48 hours after onset；
- •Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage；
- •Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.
- •Patients will be excluded if they meet any of the following criteria:
- •Hematoma involving other regions such as the supratentorial compartment, basal ganglia, thalamus, midbrain, or ventricles.
- •Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage；
- •Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000/µL; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage；
- •Current or probable pregnancy；
- •Patients with concurrent severe illness likely to influence outcome assessment；
- •Difficulty in follow-up or poor compliance due to any cause.
排除标准
- 未提供
研究组 & 干预措施
Robot-assisted minimally invasive puncture and aspiration surgery
The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage
干预措施: Robot-assisted minimally invasive puncture and aspiration surgery (Procedure)
Robot-assisted minimally invasive puncture and aspiration surgery
The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage
干预措施: Standard medical management (Other)
Standard medical management
The control group will undergo conventional medical conservative management.
干预措施: Standard medical management (Other)
结局指标
主要结局
Survival rate
时间窗: 60 days
60 days survival rate after follow-up
次要结局
- Ordinal shift in mRS scores at 60 days and 6 months(60 days and 6 months)
- Favorable functional outcome at 60 days and 6 months (mRS 0-1)(60 days and 6 months)
- Functional independence at 60 days and 6 months (mRS 0-2)(60 days and 6 months)
- Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire(60 days and 6 months)
- Utility-weighted mRS at 60 days and 6 months(60 days and 6 months)
- Cognitive function at 60 days and 6 months(60 days and 6 months)
- Total length of hospital stay(60 days)
- Costs during hospitalization(60 days)
- ICU length of stay(60 days)
- Brainstem hematoma clearance rate on postoperative days 1, 3, and 7(1, 3, and 7 days)
- Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis(14 days)
研究者
Yanbing Yu
Chief of Neurosurgery
China-Japan Friendship Hospital