European stroke journal · 2026
The Dutch Intracerebral Haemorrhage Surgery Trial: study protocol for a randomised clinical trial of minimally invasive endoscopy-guided surgery in patients with spontaneous, supratentorial intracerebral haemorrhage.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Wilting Floor N H, Wolsink Axel, Colmer Nadia H C, Schreuder Floris H B M, Brouwers H Bart, Boogaarts Hieronymus D, Dippel Diederik W J, Hannink Gerjon, Jolink Wilmar M T, Verbaan Dagmar, Wermer Marieke J H, Dammers Ruben, Klijn Catharina J M
Аннотация
BACKGROUND: Growing evidence suggests that surgical treatment of ICH may be beneficial, particularly when performed early, with minimally invasive procedures, and in patients with lobar ICH. However, the available evidence is limited by risk of bias, heterogeneity and imprecision, and data supporting a beneficial effect in deep ICH is limited.
AIM: To determine whether early minimally invasive endoscopy-guided surgery in addition to standard medical management improves functional outcome in patients with spontaneous supratentorial ICH, compared with standard medical management alone.
STUDY DESIGN: The Dutch ICH Surgery Trial (DIST) is a multicentre, prospective, randomised trial with open-label treatment and blinded end-point assessment conducted in 11 neurosurgical centres in the Netherlands. Six hundred adult patients with spontaneous supratentorial ICH with a haematoma volume ≥ 10 mL and an NIHSS score ≥2 will be enrolled. Patients will be randomised (1:1) to minimally invasive endoscopy-guided surgery within 8 hours of symptom onset in addition to standard medical management, or to standard medical management alone.
STUDY ENDPOINTS: The primary outcome is the mRS score at 180 days. Secondary outcomes include the mRS at 90 and 365 days, safety and technical efficacy outcomes, quality-of-life measures and health economic evaluations up to 365 days. In addition, DIST will investigate blood and imaging biomarkers of secondary brain injury.
SUMMARY: Dutch ICH Surgery Trial assesses the efficacy of early endoscopy-guided surgery for patients with supratentorial ICH. Recruitment started in November 2022; as of October 2025, 235 participants have been enrolled. Completion of recruitment is expected in 2027.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05460793.
AIM: To determine whether early minimally invasive endoscopy-guided surgery in addition to standard medical management improves functional outcome in patients with spontaneous supratentorial ICH, compared with standard medical management alone.
STUDY DESIGN: The Dutch ICH Surgery Trial (DIST) is a multicentre, prospective, randomised trial with open-label treatment and blinded end-point assessment conducted in 11 neurosurgical centres in the Netherlands. Six hundred adult patients with spontaneous supratentorial ICH with a haematoma volume ≥ 10 mL and an NIHSS score ≥2 will be enrolled. Patients will be randomised (1:1) to minimally invasive endoscopy-guided surgery within 8 hours of symptom onset in addition to standard medical management, or to standard medical management alone.
STUDY ENDPOINTS: The primary outcome is the mRS score at 180 days. Secondary outcomes include the mRS at 90 and 365 days, safety and technical efficacy outcomes, quality-of-life measures and health economic evaluations up to 365 days. In addition, DIST will investigate blood and imaging biomarkers of secondary brain injury.
SUMMARY: Dutch ICH Surgery Trial assesses the efficacy of early endoscopy-guided surgery for patients with supratentorial ICH. Recruitment started in November 2022; as of October 2025, 235 participants have been enrolled. Completion of recruitment is expected in 2027.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05460793.