To clip or to coil for unruptured intracranial aneurysm?: A protocol of randomized controlled trial.

ABSTRACT

INTRODUCTION: Microsurgical clipping and endovascular coiling are the main methods against unruptured intracranial aneurysm (UIA). The craniotomy of surgical clipping may increase the risk of cerebrospinal fluid leakage and infection, damage the brain tissue, produce excessive stimulation to the nerves and blood vessels around the aneurysm, and cause the corresponding neurological deficit. Endovascular coiling could significantly reduce the mortality and disability rate than surgical clipping technique, which made endovascular coiling to become the first choice for the treatment of UIA. However, the long-term results showed attenuated favorable outcomes of coiling over clipping, so it is still in debate whether to clip or to coil. Therefore, we try to conduct a randomized, controlled, prospective trial to assess the long term safety of endovascular coiling therapy against UIA compared with microsurgical clipping technique. METHODS: Parallel-group randomization (11) is generated through the random number generator in Microsoft Excel 2010. In this trial, blinding to patients, physicians, and outcome assessors is not possible. Endovascular coiling or surgical clipping will be performed once for each patient in treatment group or control group, respectively. The mRS, overall mortality rate, disability rate, morbidity rate, and occurrence of a major aneurysm recurrence measured at 6 month and 1 year will be recorded. CONCLUSIONS: The findings will be helpful for the choice of endovascular coiling or surgical clipping by assessing the long term efficacy and safety of both operations against UIA. TRIAL REGISTRATION OSF Registration number DOI 10.17605/OSF.IO/QYE9F.