Roboticky asistovaná miniinvazivní chirurgie krvácení mozkového kmene (RAINBOW-BSH)
Výzkum minimálně invazivních chirurgických strategií pro krvácení mozkového kmene s pomocí robotiky
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yanbing Yu, M.D.
- Telefonní číslo: +86-13901114963
- E-mail: yuyanbing123@126.com
Studijní záloha kontaktů
- Jméno: Yulian Zhang, M.D.
- Telefonní číslo: +86-13051581507
- E-mail: 398824625@qq.com
Studijní místa
-
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Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100029
- Nábor
- China-Japan Friendship Hospital
-
Kontakt:
- Yulian Zhang, M.D.
- Telefonní číslo: +86-13051581507
- E-mail: 398824625@qq.com
-
Kontakt:
- Yanbing Yu, M.D.
- Telefonní číslo: 13901114963
- E-mail: yuyanbing123@126.com
-
Dílčí vyšetřovatel:
- Xu Yang, M.D.
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Beijing, Beijing Municipality, Čína, 100049
- Nábor
- Aerospace Center Hospital
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Kontakt:
- Feng Yin, M.D.
- Telefonní číslo: +86-13381207600
- E-mail: yinf897@163.com
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Kontakt:
- Hui Chen, M.D.
- Telefonní číslo: +86-13810520648
- E-mail: 16564583@qq.com
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Guangxi
-
Nanning, Guangxi, Čína, 530021
- Nábor
- The First Affiliated Hospital of Guangxi Medical University
-
Kontakt:
- DAQIN FENG
- Telefonní číslo: +8619914884494
- E-mail: 13807713918@163.com
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Hebei
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Shijiazhuang, Hebei, Čína, 100190
- Nábor
- Hebei Provincial People's Hospital
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Kontakt:
- Tao Qian, M.D.
- Telefonní číslo: +86-15931423666
- E-mail: qt1966a@163.com
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Kontakt:
- Yang Li, M.D.
- Telefonní číslo: +86-18632109423
- E-mail: 772355464@qq.com
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Jiangsu
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Nanjing, Jiangsu, Čína, 210008
- Nábor
- Nanjing Drum Tower Hospital
-
Kontakt:
- CHUNHUA HANG
- Telefonní číslo: +8613813379309
- E-mail: hang1965@nju.edu.cn
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Nantong, Jiangsu, Čína, 226001
- Nábor
- Affiliated Hospital of Nantong University
-
Kontakt:
- JIANHONG SHEN
- Telefonní číslo: +8613506287516
- E-mail: tysjh@163.com
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Jiangxi
-
Nanchang, Jiangxi, Čína, 330006
- Nábor
- The Second Affiliated Hospital of Nanchang University
-
Kontakt:
- HUA GUO
- Telefonní číslo: +8613697081718
- E-mail: ndefy02014@ncu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200040
- Nábor
- Huashan Hospital Fudan University
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Kontakt:
- JIN HU
- Telefonní číslo: +8618930174565
- E-mail: hujin@fudan.edu.cn
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Shanghai, Shanghai Municipality, Čína, 201199
- Nábor
- Shanghai Minhang District Central Hospital
-
Kontakt:
- FULIN XU
- Telefonní číslo: +8618121270156
- E-mail: 18918169183@163.com
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Shanghai, Shanghai Municipality, Čína, 200120
- Nábor
- Shanghai East Hospital, Tongji University
-
Kontakt:
- CHUNLONG ZHONG
- Telefonní číslo: +8613917920669
- E-mail: drchunlongzhong@tongji.edu.cn
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Shanghai, Shanghai Municipality, Čína, 201508
- Nábor
- Jinshan Hospital, Fudan University
-
Kontakt:
- ERSONG WANG
- Telefonní číslo: wersong@aliyun +8618930815670
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Tianjin Municipality
-
Tianjin, Tianjin Municipality, Čína, 300350
- Nábor
- Tianjin Huanhu Hospital
-
Kontakt:
- JIE ZUO
- Telefonní číslo: +8618920195507
- E-mail: luckywhg@163.com
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Zhejiang
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Hangzhou, Zhejiang, Čína, 310009
- Nábor
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Kontakt:
- Gao Chen
- Telefonní číslo: +8613738194475
- E-mail: d-chengao@zju.edu.cn
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Jinhua, Zhejiang, Čína, 321000
- Nábor
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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Kontakt:
- MINFENG TONG
- Telefonní číslo: +8613646694178
- E-mail: Tmfhyj@sina.com
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Wenzhou, Zhejiang, Čína, 325000
- Nábor
- The First Affiliated Hospital of Wenzhou Medical University
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Kontakt:
- QUN LI
- Telefonní číslo: +8615858002900
- E-mail: garylina@126.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Participants must meet all of the following inclusion criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Robot-assisted minimally invasive puncture and aspiration surgery
The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage |
Positioning and surgical operation will be performed according to the robot navigation system protocols. Preoperative imaging data will be used for precise surgical planning, including the construction of a three-dimensional (3D) preoperative visualization model. The 3D reconstruction and CT data will be imported into the AI robot-assisted stereotactic system, which, after mapping to the patient's skull, automatically designs the surgical target, calculates coordinate values, plans the puncture trajectory, and determines the cranial entry point. Different surgical approaches will be selected based on the location and shape of the hematoma, and individualized parameters, including puncture direction and trajectory length, will be generated for each patient. During the procedure, the robot will assist with stereotactic puncture, while the patient's heart rate and blood pressure are closely monitored.
Ostatní jména:
According to the "Chinese Neurosurgical Expert Consensus on the Diagnosis and Treatment of Primary Brainstem Hemorrhage", conventional medical treatment includes oxygen therapy, specialized nursing care, blood pressure control (maintaining BP at ≤140/90 mmHg), sedation, intracranial pressure reduction, arousal promotion, gastric protection, maintenance of internal homeostasis, infection prevention, neuro-nutrition, brain function support, nutritional support, and overall systemic management; For comatose patients, ensure a patent airway, provide nebulization and sputum clearance, prevent respiratory depression, and improve respiratory function. Closely monitor the patient's condition and provide active symptomatic treatment as needed. Regular cranial CT scans are performed to evaluate intracranial status, and in cases of ventricular hemorrhage or obstructive hydrocephalus, lateral ventricular puncture and drainage may be performed.
Ostatní jména:
|
|
Aktivní komparátor: Standard medical management
The control group will undergo conventional medical conservative management. |
According to the "Chinese Neurosurgical Expert Consensus on the Diagnosis and Treatment of Primary Brainstem Hemorrhage", conventional medical treatment includes oxygen therapy, specialized nursing care, blood pressure control (maintaining BP at ≤140/90 mmHg), sedation, intracranial pressure reduction, arousal promotion, gastric protection, maintenance of internal homeostasis, infection prevention, neuro-nutrition, brain function support, nutritional support, and overall systemic management; For comatose patients, ensure a patent airway, provide nebulization and sputum clearance, prevent respiratory depression, and improve respiratory function. Closely monitor the patient's condition and provide active symptomatic treatment as needed. Regular cranial CT scans are performed to evaluate intracranial status, and in cases of ventricular hemorrhage or obstructive hydrocephalus, lateral ventricular puncture and drainage may be performed.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Survival rate
Časové okno: 60 days
|
60 days survival rate after follow-up |
60 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Ordinal shift in mRS scores at 60 days and 6 months
Časové okno: 60 days and 6 months
|
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. |
60 days and 6 months
|
|
Favorable functional outcome at 60 days and 6 months (mRS 0-1)
Časové okno: 60 days and 6 months
|
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. |
60 days and 6 months
|
|
Functional independence at 60 days and 6 months (mRS 0-2)
Časové okno: 60 days and 6 months
|
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. |
60 days and 6 months
|
|
Health-related quality of life (HRQoL) at 60 days and 6 months, assessed by the EQ-5D-5L questionnaire
Časové okno: 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
Časové okno: 60 days and 6 months
|
The modified Rankin Scale (mRS) is a standardized tool used to assess the neurological recovery status of stroke patients. The scale is divided into seven levels, ranging from 0 to 6. Higher scores indicate more severe patient conditions. |
60 days and 6 months
|
|
Cognitive function at 60 days and 6 months
Časové okno: 60 days and 6 months
|
Cognitive function at 60 days and 6 months |
60 days and 6 months
|
|
Total length of hospital stay
Časové okno: 60 days
|
Total length of hospital stay |
60 days
|
|
Costs during hospitalization
Časové okno: 60 days
|
Costs during hospitalization |
60 days
|
|
ICU length of stay
Časové okno: 60 days
|
ICU length of stay |
60 days
|
|
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Časové okno: 1, 3, and 7 days
|
The change in hematoma volume compared to the preoperative CT scan was assessed 1, 3, and 7 days postoperatively. |
1, 3, and 7 days
|
|
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis
Časové okno: 14 days
|
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis |
14 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Yanbing Yu, M.D., China-Japan Friendship Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Další relevantní podmínky MeSH
Další identifikační čísla studie
- 01084205031
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