Chirurgie mini-invasive assistée par robot pour l'hémorragie du tronc cérébral (RAINBOW-BSH)
Recherche sur les stratégies chirurgicales mini-invasives pour l'hémorragie du tronc cérébral assistées par la robotique
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yanbing Yu, M.D.
- Numéro de téléphone: +86-13901114963
- E-mail: yuyanbing123@126.com
Sauvegarde des contacts de l'étude
- Nom: Yulian Zhang, M.D.
- Numéro de téléphone: +86-13051581507
- E-mail: 398824625@qq.com
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100029
- Recrutement
- China-Japan Friendship Hospital
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Contact:
- Yulian Zhang, M.D.
- Numéro de téléphone: +86-13051581507
- E-mail: 398824625@qq.com
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Contact:
- Yanbing Yu, M.D.
- Numéro de téléphone: 13901114963
- E-mail: yuyanbing123@126.com
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Sous-enquêteur:
- Xu Yang, M.D.
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Beijing, Beijing Municipality, Chine, 100049
- Recrutement
- Aerospace Center Hospital
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Contact:
- Feng Yin, M.D.
- Numéro de téléphone: +86-13381207600
- E-mail: yinf897@163.com
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Contact:
- Hui Chen, M.D.
- Numéro de téléphone: +86-13810520648
- E-mail: 16564583@qq.com
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Guangxi
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Nanning, Guangxi, Chine, 530021
- Recrutement
- The First Affiliated Hospital of Guangxi Medical University
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Contact:
- DAQIN FENG
- Numéro de téléphone: +8619914884494
- E-mail: 13807713918@163.com
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Hebei
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Shijiazhuang, Hebei, Chine, 100190
- Recrutement
- Hebei Provincial People's Hospital
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Contact:
- Tao Qian, M.D.
- Numéro de téléphone: +86-15931423666
- E-mail: qt1966a@163.com
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Contact:
- Yang Li, M.D.
- Numéro de téléphone: +86-18632109423
- E-mail: 772355464@qq.com
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Jiangsu
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Nanjing, Jiangsu, Chine, 210008
- Recrutement
- Nanjing Drum Tower Hospital
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Contact:
- CHUNHUA HANG
- Numéro de téléphone: +8613813379309
- E-mail: hang1965@nju.edu.cn
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Nantong, Jiangsu, Chine, 226001
- Recrutement
- Affiliated Hospital of Nantong University
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Contact:
- JIANHONG SHEN
- Numéro de téléphone: +8613506287516
- E-mail: tysjh@163.com
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Jiangxi
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Nanchang, Jiangxi, Chine, 330006
- Recrutement
- The Second Affiliated Hospital of Nanchang University
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Contact:
- HUA GUO
- Numéro de téléphone: +8613697081718
- E-mail: ndefy02014@ncu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200040
- Recrutement
- Huashan Hospital Fudan University
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Contact:
- JIN HU
- Numéro de téléphone: +8618930174565
- E-mail: hujin@fudan.edu.cn
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Shanghai, Shanghai Municipality, Chine, 201199
- Recrutement
- Shanghai Minhang District Central Hospital
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Contact:
- FULIN XU
- Numéro de téléphone: +8618121270156
- E-mail: 18918169183@163.com
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Shanghai, Shanghai Municipality, Chine, 200120
- Recrutement
- Shanghai East Hospital, Tongji University
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Contact:
- CHUNLONG ZHONG
- Numéro de téléphone: +8613917920669
- E-mail: drchunlongzhong@tongji.edu.cn
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Shanghai, Shanghai Municipality, Chine, 201508
- Recrutement
- Jinshan Hospital, Fudan University
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Contact:
- ERSONG WANG
- Numéro de téléphone: wersong@aliyun +8618930815670
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Chine, 300350
- Recrutement
- Tianjin Huanhu Hospital
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Contact:
- JIE ZUO
- Numéro de téléphone: +8618920195507
- E-mail: luckywhg@163.com
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310009
- Recrutement
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Contact:
- Gao Chen
- Numéro de téléphone: +8613738194475
- E-mail: d-chengao@zju.edu.cn
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Jinhua, Zhejiang, Chine, 321000
- Recrutement
- Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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Contact:
- MINFENG TONG
- Numéro de téléphone: +8613646694178
- E-mail: Tmfhyj@sina.com
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Wenzhou, Zhejiang, Chine, 325000
- Recrutement
- The First Affiliated Hospital of Wenzhou Medical University
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Contact:
- QUN LI
- Numéro de téléphone: +8615858002900
- E-mail: garylina@126.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
|
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Comparateur actif: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Survival rate
Délai: 60 days
|
60 days survival rate after follow-up |
60 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ordinal shift in mRS scores at 60 days and 6 months
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 60 days and 6 months
|
Cognitive function at 60 days and 6 months |
60 days and 6 months
|
|
Total length of hospital stay
Délai: 60 days
|
Total length of hospital stay |
60 days
|
|
Costs during hospitalization
Délai: 60 days
|
Costs during hospitalization |
60 days
|
|
ICU length of stay
Délai: 60 days
|
ICU length of stay |
60 days
|
|
Brainstem hematoma clearance rate on postoperative days 1, 3, and 7
Délai: 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
Délai: 14 days
|
Incidence of related complications within 14 days, including pneumonia, aphasia, seizures, and lower-extremity deep vein thrombosis |
14 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Yanbing Yu, M.D., China-Japan Friendship Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 01084205031
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The study has not yet begun; we will decide once recruitment starts.
Informations sur les médicaments et les dispositifs, documents d'étude
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