Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage

Robotic Surgical Procedures Clinical Trial

Official title:

Research on Minimally Invasive Surgical Strategies for Brainstem Hemorrhage Assisted by Robotics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459427
• Other study ID #: 01084205031
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2025
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: China-Japan Friendship Hospital
• Contact: Yanbing Yu, M.D.
• Phone: +86-13901114963
• Email: yuyanbing123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hemorrhage
• Robotic Surgical Procedures

Intervention

Procedure:
• Robot-Assisted Stereotactic Brainstem Hematoma Puncture
Positioning and surgical procedures are carried out based on the use of robotic navigation equipment. Precise preoperative design is conducted using preoperative imaging data to create a preoperative three-dimensional visualization model. During surgery, robot-assisted stereotactic puncture is performed. First day, urokinase may be used as needed to assist in dissolving residual hematoma and adjusting the depth of the drainage tube. For every 10 mL of hematoma, 1 mL of 10,000 IU urokinase in 0.9% sodium chloride solution is injected, followed by flushing with 2 mL of 0.9% sodium chloride solution through the tube after closing it for 2 hours, and then reopening it. Urokinase injections into the drainage tube are used 1-2 times daily to facilitate hematoma drainage. Third day, if the residual hematoma volume is <3 mL or if the drainage tube has been in place for >5 days, the drainage tube is removed.

Drug:
• Conservative non-surgical treatment
Oxygen therapy, intensive care, maintaining stable blood pressure (targeting 140/90 mmHg), sedation, intracranial pressure control, arousal promotion, gastric protection, maintaining homeostasis, infection control, neurological nutrition, brain function improvement, nutritional support, general condition improvement, and other treatments are provided. For comatose patients, ensuring airway patency, administering nebulized expectorants, preventing respiratory depression, improving respiratory function, and performing tracheostomy if necessary are part of the care plan. Close monitoring of patients' conditions and proactive symptomatic treatment are prioritized. Regular follow-up cranial CT scans are scheduled to monitor intracranial conditions. Ventricular puncture drainage is considered if there is concomitant intraventricular hemorrhage or obstructive hydrocephalus (with patient consent).

Locations

Country	Name	City	State
China	Aerospace Center Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Hebei Provincial People's Hospital	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Yanbing Yu

Country where clinical trial is conducted

China, 

References & Publications (1)

Lui TN, Fairholm DJ, Shu TF, Chang CN, Lee ST, Chen HR. Surgical treatment of spontaneous cerebellar hemorrhage. Surg Neurol. 1985 Jun;23(6):555-8. doi: 10.1016/0090-3019(85)90002-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	Six-month survival rate after follow-up	Six-month
Secondary	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
Secondary	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
Secondary	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
Secondary	Hematoma clearance volume	The change in hematoma volume compared to the preoperative CT scan was assessed three days postoperatively.	3 days
Secondary	Duration of ICU stay	Duration of ICU stay	six months
Secondary	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
Secondary	adverse events and complications	Incidence of adverse events and complications	six months
Secondary	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