Chirurgia mini-invasiva robotizzata per l’emorragia del tronco encefalico (RAINBOW-BSH)
Ricerca sulle strategie chirurgiche minimamente invasive per l'emorragia del tronco cerebrale assistita dalla robotica
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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Yanbing Yu, M.D.
- Numero di telefono: +86-13901114963
- Email: yuyanbing123@126.com
Backup dei contatti dello studio
- Nome: Yulian Zhang, M.D.
- Numero di telefono: +86-13051581507
- Email: 398824625@qq.com
Luoghi di studio
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100029
- Reclutamento
- China-Japan Friendship Hospital
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Contatto:
- Yulian Zhang, M.D.
- Numero di telefono: +86-13051581507
- Email: 398824625@qq.com
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Contatto:
- Yanbing Yu, M.D.
- Numero di telefono: 13901114963
- Email: yuyanbing123@126.com
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Sub-investigatore:
- Xu Yang, M.D.
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Beijing, Beijing Municipality, Cina, 100049
- Reclutamento
- Aerospace Center Hospital
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Contatto:
- Feng Yin, M.D.
- Numero di telefono: +86-13381207600
- Email: yinf897@163.com
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Contatto:
- Hui Chen, M.D.
- Numero di telefono: +86-13810520648
- Email: 16564583@qq.com
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Guangxi
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Nanning, Guangxi, Cina, 530021
- Reclutamento
- The First Affiliated Hospital of Guangxi Medical University
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Contatto:
- DAQIN FENG
- Numero di telefono: +8619914884494
- Email: 13807713918@163.com
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Hebei
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Shijiazhuang, Hebei, Cina, 100190
- Reclutamento
- Hebei Provincial People's Hospital
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Contatto:
- Tao Qian, M.D.
- Numero di telefono: +86-15931423666
- Email: qt1966a@163.com
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Contatto:
- Yang Li, M.D.
- Numero di telefono: +86-18632109423
- Email: 772355464@qq.com
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Jiangsu
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Nanjing, Jiangsu, Cina, 210008
- Reclutamento
- Nanjing Drum Tower Hospital
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Contatto:
- CHUNHUA HANG
- Numero di telefono: +8613813379309
- Email: hang1965@nju.edu.cn
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Nantong, Jiangsu, Cina, 226001
- Reclutamento
- Affiliated Hospital of Nantong University
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Contatto:
- JIANHONG SHEN
- Numero di telefono: +8613506287516
- Email: tysjh@163.com
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Jiangxi
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Nanchang, Jiangxi, Cina, 330006
- Reclutamento
- The Second Affiliated Hospital of Nanchang University
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Contatto:
- HUA GUO
- Numero di telefono: +8613697081718
- Email: ndefy02014@ncu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200040
- Reclutamento
- Huashan Hospital Fudan University
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Contatto:
- JIN HU
- Numero di telefono: +8618930174565
- Email: hujin@fudan.edu.cn
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Shanghai, Shanghai Municipality, Cina, 201199
- Reclutamento
- Shanghai Minhang District Central Hospital
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Contatto:
- FULIN XU
- Numero di telefono: +8618121270156
- Email: 18918169183@163.com
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Shanghai, Shanghai Municipality, Cina, 200120
- Reclutamento
- Shanghai East Hospital, Tongji University
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Contatto:
- CHUNLONG ZHONG
- Numero di telefono: +8613917920669
- Email: drchunlongzhong@tongji.edu.cn
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Shanghai, Shanghai Municipality, Cina, 201508
- Reclutamento
- Jinshan Hospital, Fudan University
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Contatto:
- ERSONG WANG
- Numero di telefono: wersong@aliyun +8618930815670
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 300350
- Reclutamento
- Tianjin Huanhu Hospital
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Contatto:
- JIE ZUO
- Numero di telefono: +8618920195507
- Email: luckywhg@163.com
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310009
- Reclutamento
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Contatto:
- Gao Chen
- Numero di telefono: +8613738194475
- Email: d-chengao@zju.edu.cn
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Jinhua, Zhejiang, Cina, 321000
- Reclutamento
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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Contatto:
- MINFENG TONG
- Numero di telefono: +8613646694178
- Email: Tmfhyj@sina.com
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Wenzhou, Zhejiang, Cina, 325000
- Reclutamento
- The First Affiliated Hospital of Wenzhou Medical University
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Contatto:
- QUN LI
- Numero di telefono: +8615858002900
- Email: garylina@126.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
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.
Altri nomi:
|
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Comparatore attivo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Survival rate
Lasso di tempo: 60 days
|
60 days survival rate after follow-up |
60 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Ordinal shift in mRS scores at 60 days and 6 months
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 60 days and 6 months
|
Cognitive function at 60 days and 6 months |
60 days and 6 months
|
|
Total length of hospital stay
Lasso di tempo: 60 days
|
Total length of hospital stay |
60 days
|
|
Costs during hospitalization
Lasso di tempo: 60 days
|
Costs during hospitalization |
60 days
|
|
ICU length of stay
Lasso di tempo: 60 days
|
ICU length of stay |
60 days
|
|
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Lasso di tempo: 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
Lasso di tempo: 14 days
|
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis |
14 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Yanbing Yu, M.D., China-Japan Friendship Hospital
Pubblicazioni e link utili
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Altri numeri di identificazione dello studio
- 01084205031
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
The study has not yet begun; we will decide once recruitment starts.
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