Study design for a prospective randomized trial of extracranial-intracranial bypass surgery for adults with moyamoya disease and hemorrhagic onset--the Japan Adult Moyamoya Trial Group.
This article summarizes the study design and organization of a multicenter, prospective randomized trial of extracranial-intracranial (EC-IC) bypass for treating adult patients with moyamoya disease who suffered episodes of intracranial bleeding. The Japan Adult Moyamoya Trial will determine whether the combination of EC-IC bypass with risk factor modifications affects the prognosis and the incidence of recurrent bleeding attacks. Direct bypass such as superficial temporal artery-middle cerebral artery anastomosis is essential and indirect bypass procedures alone such as encephalo-duro-arterio-synangiosis or encephalo-myo-synangiosis are not dealt with in this trial. Power calculations are based on an assumption of alpha=0.05 with an annual event rate of 8% significant morbidity and mortality per year in the non-surgical group and 4% in the surgical group. The study has an 80% rate of accuracy for detection of a 20% difference between the two groups in events in a 5-year follow up.
Miyamoto
Susumu
S
Department of Neurosurgery, National Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan. miy@hsp.ncvc.go.jp
D000328:Adult; D002543:Cerebral Hemorrhage / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control / Q000601:surgery*; D002548:Cerebral Revascularization / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D007564:Japan; D009072:Moyamoya Disease / Q000150:complications* / Q000601:surgery*; D012107:Research Design; D055502:Secondary Prevention