Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage
NCT Number: NCT06459427
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Brain Stem Hemorrhage|Robotic Surgical Procedures|Stereotactic Techniques
Interventions: PROCEDURE: Robot-Assisted Stereotactic Brainstem Hematoma Puncture|DRUG: Conservative non-surgical treatment
Sponsor: Yanbing Yu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-07
Completion Date: 2027-12
Locations: China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|Aerospace Center Hospital, Beijing, Beijing, 100049, China|Hebei Provincial People's Hospital, Shijiazhuang, Hebei, 100190, China

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.

Primary Outcome Measures: survival rate, Six-month survival rate after follow-up, Six-month
Secondary Outcome Measures: The favorable prognosis rate for modified Rankin Scale (mRS) .(proportion of patients with mRS ≤ 3), 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., six months|The favorable prognosis rate for Activities of Daily Living - Modified Barthel Index (ADL-MBI) .(proportion of patients with ADL-MBI ≥ 3), 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., six months|The modified Rankin Scale (mRS), 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., 30 days|Hematoma clearance volume, The change in hematoma volume compared to the preoperative CT scan was assessed three days postoperatively., 3 days|Duration of ICU stay, Duration of ICU stay, six months|Mean latency of motor-evoked potential (MEP) in upper and lower limbs, 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., 2 weeks|adverse events and complications, Incidence of adverse events and complications, six months|The number of patients undergoing repeat surgery, The number of patients requiring secondary surgery for postoperative complications such as rebleeding, tension pneumocephalus, intracranial infection, and persistent coma assessment., six months