Shunt versus stent in idiopathic intracranial hypertension
Research type
Research Study
Full title
Lumboperitoneal shunt versus venous sinus stent as a first line treatment of idiopathic intracranial hypertension patients, a feasibility study
IRAS ID
189116
Contact name
Ahmed Toma
Contact email
Sponsor organisation
Joint UCLH/UCL Biomedical Research Unit
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
Idiopathic intracranial hypertension (IIH) is a condition that is characterized by increased pressure within the skull (intracranial pressure (ICP)) in the absence of any central nervous system disease, structural abnormality and normal composition of the cerebrospinal fluid (CSF). CSF is a clear fluid that is secreted by the brain and is found within its cavities.
IIH initial management is medical in the first instance. In some patients, however, surgical management is necessary. The conventional surgical intervention is by diverting the CSF to a body cavity using a shunt, to reduce the pressure inside the skull. The commonest form shunt used in IIH is Lumboperitoneal shunt (LP). Shunt surgery is not without risk. Patients also frequently require repeated admissions and further operations for shunt complications.
The brain receives a relatively large amount of arterial blood pumped by the heart. Most of this blood leaves the skull through venous structures called cerebral venous sinuses. Narrowing of these sinuses (stenosis) is frequent in IIH patients. It has been found that expanding the narrow section of the sinus by deploying a delicate pipeline (a stent) across the stenosis area can improve venous drainage and reduce ICP. Accordingly, stent insertion has been increasingly used world wide for treatment of IIH patients with promising results. Once stent is deployed, it cannot be retrieved. The complications rate is small.There is no clear evidence regarding the actual benefit of stent and certainly no studies has been done to compare it with the traditional shunt insertion method.
In this study, the only difference from the current clinical practice would be at the stage of deciding the treatment method. Either a stent or a shunt will be chose randomly. All other aspects of management will be identical to those for patients outside the study.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0282
Date of REC Opinion
10 May 2016
REC opinion
Further Information Favourable Opinion