Randomized Controlled Trial Evaluating the Efficacy of Venous Sinus Stenting Versus Neurosurgical Internal Ventricular Shunt on Papillary Edema in the Management of Idiopathic Intracranial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Resolution of the papillary edema
研究概览
简要总结
Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses and whose origin remains unknown.
This hypertension can lead to papillary edema (OP) which can lead to a narrowing of the visual field and progress to blindness. Along with weight reduction, acetazolamide, which reduces the production of cerebrospinal fluid (CSF), is prescribed as a first-line treatment. Its efficacy is inconsistent in resolving papillary edema and there are many side effects.
In the event of ineffectiveness or dependence on acetazolamide associated with hygiene and dietetic rules, a second line of therapy is then considered: neurosurgical (internal shunt of the LCS) or endovascular (venous stenting) treatment.
These invasive techniques have each proven their effectiveness in the rapid and permanent resorption of OP, allowing improvement or preservation of visual function. In terms of induced morbidity, the superiority of one technique over the other, if it exists, has not been established.
Our objective is to compare the efficacy, safety, and safety of LCS bypass surgery versus venous sinus stenting in HTICi with moderate to severe visual impairment after failure of medical treatment defined by the absence of resorption of the OP after several months
详细描述
Intervention 1 Name : internal ventricular shunt (neurosurgery)
Other name [facultatif] :
Description :
The internal ventricular shunt consists of the introduction of a catheter from a lateral ventricle into the atrium or peritoneum. It is associated with a valve whose opening pressure is adjustable. The goal is that cerebrospinal fluid can be absorbed extra-cranial.
Intervention 2 Name : endovacascular stenting (interventional neuroradiology)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or over
- •HTICi proven greater than 25cm of water
- •Presence of papillary edema (grade> 0 on the Frisen scale)
- •Stenosis of at least one transverse sinus on MRI
- •Failure of medical treatment and surgical / interventional indication defined by the medical team taking care of the patient
- •Consent to participate in the study
排除标准
- •Fulminant HTICi
- •Contraindication to antiplatelet aggregation
- •Contraindication to one or the other of the interventions under study
- •Pregnant or breastfeeding woman
研究组 & 干预措施
internal ventricular shunt (neurosurgery)
The internal ventricular shunt consists of the introduction of a catheter from a lateral ventricle into the atrium or peritoneum. It is associated with a valve whose opening pressure is adjustable. The goal is that cerebrospinal fluid can be absorbed extra-cranial
干预措施: Neurosurgical internal ventricular shunt (Procedure)
endovacascular stenting (interventional neuroradiology)
The placement of a vascular endoprosthesis (stent) is an interventional neuroradiology procedure aimed, by venous approach (percutaneous puncture), to restore the diameter of a venous sinus. It requires 6 months of antiplatelet aggregation. The aim is to allow better venous drainage from the brain to increase the absorption of cerebrospinal fluid.
干预措施: venous sinus stenting (Procedure)
结局指标
主要结局
Resolution of the papillary edema
时间窗: 3 months after the procedure
Resolution of the papillary edema at 3 months defined by: disappearance of the edema (grade 0 on the Frisén scale) or reduction of at least 2 grades of the edema compared to baseline without deterioration of the visual field (Humphrey).
次要结局
未报告次要终点