Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage (MISICH)

Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage

Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial

Jingzhou Central Hospital, Wuhan No.1 Hospital, Yichang Central People's Hospital, Second Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, Tang-Du Hospital, First Affiliated Hospital, Sun Yat-Sen University, Jiangmen Central Hospital, Jilin Province People's Hospital, Siping Central Hospital, Minzu Hospital of Guangxi Zhuang Autonomous Region, Taihe Hospital

The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains controversial. Two main types of minimally invasive surgery, endoscopic evacuation and stereotactic aspiration, have been attempted for hematoma removal and show some advantages. However, prospective and controlled studies are still lacking. This is a multi-center randomized controlled trial designed to determine whether minimally invasive hematoma evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap craniotomy group in a 1:1:1 ratio.

Hypertensive intracerebral hemorrhage (HICH) is the most common hemorrhagic stroke. The morbidity and mortality exceed 60% and only 12% patients could live independently. The choice of surgical or conservative treatment for patients with HICH is controversial. Some minimally invasive neurosurgeries have been applied to hematoma evacuation and may improve prognosis to some extent. In endoscopic evacuation, a small burr hole is created and hematoma is removed through suction and irrigation under neuroendoscope. Endoscopic surgical evacuation promise to maximize hematoma evacuation while minimizing damage to normal tissue. Stereotactic aspiration uses image guidance to place a catheter into the main body of the hematoma and aspirate blood. It is estimated that 720 patients (240 patients in each treatment group) would provide 90% power and a type I error probability of .05 to detect an effect size of 13% with a 10% dropout rate taken into consideration. Patients will receive endoscopic evacuation, stereotactic aspiration or craniotomy according to the results of randomization. Patients will be followed up at 7 days, 30 days and 6 months. Outcomes of different groups of patients will be collected and compared. The study is designed to find a best surgical method for hypertensive intracerebral hemorrhage.

intracerebral hemorrhage,hypertensive, minimally invasive surgery, neuroendoscopic surgery, stereotactic aspiration

The degree of disability or dependence in the daily activities. The scale runs from 0-6, running from perfect health without symptoms to death.

The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery.

The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.

Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests.

An ordinal scale used to measure performance of patients in activities of daily living. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.

Inclusion Criteria: Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume ≥25mL Adult patients with GCS score ≥5 Admitted within 24h of ictus Exclusion Criteria: Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation Concurrent head injury or history of head injury Multiple intracerebral hemorrhage Known advanced demential or disability before With indications of terminal brain hernia Severe concomitant diseases that affect life expectancy Patients having taken anti-platelet or anticoagulant drugs for a long time With severe intraventricular hemorrhage Pregnant women

Xu X, Zheng Y, Chen X, Li F, Zhang H, Ge X. Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial. Trials. 2017 Jun 28;18(1):296. doi: 10.1186/s13063-017-2041-1.