Clinical trial NCT06459427: Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage
Official title: Research on Minimally Invasive Surgical Strategies for Brainstem Hemorrhage Assisted by Robotics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Stem Hemorrhage
Robotic Surgical Procedures
Stereotactic Techniques
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: survival rate
timeFrame: Six-month
Secondary outcomes:
measure: The favorable prognosis rate for modified Rankin Scale (mRS) .(proportion of patients with mRS ≤ 3)
timeFrame: six months
measure: The favorable prognosis rate for Activities of Daily Living - Modified Barthel Index (ADL-MBI) .(proportion of patients with ADL-MBI ≥ 3)
timeFrame: six months
measure: The modified Rankin Scale (mRS)
timeFrame: 30 days
measure: Hematoma clearance volume
timeFrame: 3 days
measure: Duration of ICU stay
timeFrame: six months
measure: Mean latency of motor-evoked potential (MEP) in upper and lower limbs
timeFrame: 2 weeks
measure: adverse events and complications
timeFrame: six months
measure: The number of patients undergoing repeat surgery
timeFrame: six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: Hebei Provincial People's Hospital
state: Hebei
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yanbing Yu, M.D.
role: STUDY_CHAIR
References:
citation: 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.