Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage
- Conditions
- Brain Stem HemorrhageRobotic Surgical ProceduresStereotactic Techniques
- Interventions
- Procedure: Robot-Assisted Stereotactic Brainstem Hematoma PunctureDrug: Conservative non-surgical treatment
- Registration Number
- NCT06459427
- Lead Sponsor
- Yanbing Yu
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Diagnosed with brainstem hemorrhage via imaging, with hematoma volume calculated to be greater than 3 mL using the Tada formula in conjunction with 3D Slicer software for three-dimensional reconstruction;
- Glasgow Coma Scale (GCS) score of 3-8 at admission, with the patient in a comatose state but maintaining vital signs;
- Detailed and complete clinical data;
- Age between 18 and 70 years.
- Suspected [unless excluded by angiography or Computed Tomography angiography (CTA)/Magnetic Resonance Angiography (MRA)/Magnetic Resonance Imaging (MRI)] or untreated ruptured cerebral aneurysm, Moyamoya disease, ruptured intracranial Arteriovenous Malformations (AVM), or tumor;
- Patients with significant organ dysfunction;
- Patients with brain herniation;
- Patients with obstructive hydrocephalus;
- Patients with coagulation disorders or unstable vital signs;
- Patients with incomplete clinical data or surgical contraindications;
- Patients who used dabigatran, apixaban, and/or rivaroxaban (or drugs of the same class) before symptom onset;
Criteria for terminating the clinical trial:
- Participants who are unwilling or unable to continue the trial.
- Situations where the researcher deems it necessary to terminate the trial, such as discovering post-enrollment that a participant does not meet inclusion criteria or meets any exclusion criteria.
- Occurrence of intolerable adverse events or serious adverse events, where the researcher judges that the risk to the participant of continuing the trial outweighs the benefits.
- Loss to follow-up. (If a participant withdraws from the study due to adverse events, the researcher must take active measures to provide symptomatic treatment.)
Dropout Criteria:
Participants who have provided informed consent and passed screening to enter the trial but fail to complete the observation period specified in the protocol will be treated as dropouts. If a participant is lost to follow-up or fails to complete the assessment on time, the study coordinator must record this in the online registration system. A participant will be considered "lost to follow-up" if they cannot be contacted for 6 months. Every effort must be made to contact participants at each follow-up time point, even if they could not be reached at the previous time point. Loss to follow-up is unacceptable, and in such cases, the researchers at the study center must develop a remedial plan to improve participant tracking. All trial-related data for dropout cases should be properly preserved for both archival purposes and the necessary analysis. There is no need to replace dropout participants.
Elimination Criteria:
- Participants who were mistakenly enrolled.
- Participants with no evaluable records after enrollment.
- Participants who severely violate the trial protocol during the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robot-Assisted Minimally Invasive Surgery group Robot-Assisted Stereotactic Brainstem Hematoma Puncture Neurosurgeons participating in the robot-assisted stereotactic brainstem hematoma puncture must be frontline doctors with independent surgical qualifications and the ability to manage common complications. They must undergo standardized training and certification by the host institution. All preoperative imaging data and path planning involved in the surgery are automatically saved and uploaded by the AI system, which supports review and evaluation by each unit. Robot-Assisted Minimally Invasive Surgery group Conservative non-surgical treatment Neurosurgeons participating in the robot-assisted stereotactic brainstem hematoma puncture must be frontline doctors with independent surgical qualifications and the ability to manage common complications. They must undergo standardized training and certification by the host institution. All preoperative imaging data and path planning involved in the surgery are automatically saved and uploaded by the AI system, which supports review and evaluation by each unit. Conservative non-surgical group Conservative non-surgical treatment Perioperative management refers to the conventional medical treatment methods in the "Chinese Neurosurgery Expert Consensus on the Diagnosis and Treatment of Primary Brain Stem Hemorrhage". During the medical treatment period, the patient's condition is dynamically assessed, and surgical interventions are promptly implemented in the event of exacerbation of conditions such as brain herniation.
- Primary Outcome Measures
Name Time Method survival rate Six-month Six-month survival rate after follow-up
- Secondary Outcome Measures
Name Time Method The favorable prognosis rate for modified Rankin Scale (mRS) .(proportion of patients with mRS ≤ 3) six 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. This study calculates the proportion of individuals with an mRS score of ≤ 3 at 6 months follow-up.
The favorable prognosis rate for Activities of Daily Living - Modified Barthel Index (ADL-MBI) .(proportion of patients with ADL-MBI ≥ 3) six months The Activities of Daily Living (ADL) scale is used to assess a patient's ability to independently perform basic activities in daily life such as dressing, bathing, eating, and moving around. One of the most commonly used scales globally for evaluating ADL capacity is the Modified Barthel Index (MBI). The MBI scoring system is divided into 5 levels with scores as follows: (15, 12, 8, 3, 0; 10, 8, 5, 2, 0; 5, 4, 3, 1, 0). Different levels represent varying degrees of independence, with level 1 being the lowest and level 5 being the highest, indicating higher levels of independence as the level increases. This study calculates the proportion of individuals with an ADL-MBI score of ≥ 3 at 6 months follow-up.
The modified Rankin Scale (mRS) 30 days 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.
Hematoma clearance volume 3 days The change in hematoma volume compared to the preoperative CT scan was assessed three days postoperatively.
Duration of ICU stay six months Duration of ICU stay
Mean latency of motor-evoked potential (MEP) in upper and lower limbs 2 weeks The motor-evoked potentials in the upper and lower limbs were measured using a direct current cortical stimulator (CCS-1) connected to an electromyograph/evoked potential instrument (NDI-400). The latency data of the motor-evoked potentials were collected, and their average value was calculated.
adverse events and complications six months Incidence of adverse events and complications
The number of patients undergoing repeat surgery six months The number of patients requiring secondary surgery for postoperative complications such as rebleeding, tension pneumocephalus, intracranial infection, and persistent coma assessment.
Trial Locations
- Locations (3)
Hebei Provincial People's Hospital
🇨🇳Shijiazhuang, Hebei, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Aerospace Center Hospital
🇨🇳Beijing, Beijing, China