Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial

Abstract

Background: Hypertensive intracerebral haemorrhage (HICH) is the most common form of haemorrhagic stroke with the highest morbidity and mortality of all stroke types. The choice of surgical or conservative treatment for patients with HICH remains controversial. In recent years, minimally invasive surgeries, such as endoscopic evacuation and stereotactic aspiration, have been attempted for haematoma removal and offer promise. However, research evidence on the benefits of endoscopic evacuation or stereotactic aspiration is still insufficient.

Methods/design: A multicentre, randomised controlled trial will be conducted to compare the efficacy of endoscopic evacuation, stereotactic aspiration and craniotomy in the treatment of supratentorial HICH. About 1350 eligible patients from 10 neurosurgical centres will be randomly assigned to an endoscopic group, a stereotactic group and a craniotomy group at a 1:1:1 ratio. Randomisation is undertaken using a 24-h randomisation service accessed by telephone or the Internet. All patients will receive the corresponding surgery based on their grouping. They will be followed-up at 1, 3 and 6 months after surgery. The primary outcome is the modified Rankin Scale at 6-month follow-up. Secondary outcomes include: haematoma clearance rate; Glasgow Coma Scale 7 days after surgery; rebleeding rate; intracranial infection rate; hospitalisation time; mortality at 1 month and 3 months after surgery; the Barthel Index and the WHO quality of life at 3 months and 6 months after surgery.

Discussion: The trial aims to investigate whether endoscopic evacuation and stereotactic aspiration could improve the outcome of supratentorial HICH compared with craniotomy. The trial will help to determine the best surgical method for the treatment of supratentorial HICH.

Trial registration: ClinicalTrials.gov, ID: NCT02811614 . Registered on 20 June 2016.

Keywords: Craniotomy; Endoscopic evacuation; Intracerebral haemorrhage; Randomised controlled trial; Stereotactic aspiration.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by a central ethics committee, the Institutional Review Board (IRB) of The Chinese PLA General Hospital (approval number: S2016-074-01). Any amendment will be submitted to the Local Ethics Committee. All participants will be told about the benefits, risks, rights and responsibilities of the trial and informed consent will be signed before enrolment.

Consent for publication

Not applicable. Once patients are recruited into the study, we will use numbers to represent patients’ names.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Flowchart of the study design

Fig. 2

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure: the schedule of enrolment, interventions and assessments. Abbreviations: h hour, mo month, mons months, GCS Glasgow Coma Scale, mRS modified Rankin Scale, WHOQOL the World Health Organisation Quality of Life questionnaire

Fig. 3

Haematoma volume measurement using the software 3D Slicer. a Preoperative brain computed tomography (CT) scan confirming left external capsular haemorrhage. b Automatic depiction of the haematoma using the threshold effect. c 3D reconstruction and volume measurement of the haematoma