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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
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)
Other name [facultatif] :
Description :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| internal ventricular shunt (neurosurgery) | Active Comparator | 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 |
|
| endovacascular stenting (interventional neuroradiology) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venous sinus stenting | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of the papillary edema | 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). | 3 months after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amélie Yavchitz, MD | Contact | (0)148036454 | +33 | ayavachitz@for.paris |
| Pierre Bourdillon, MD | Contact | (0)148036862 | +33 | pbourdillon@for.paris |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Bourdillon, MD | Fondation A. de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation A De Rothschild | Recruiting | Paris | Paris | 75019 | France |
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Name : internal ventricular shunt (neurosurgery)
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)
Description
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 vscription : enous drainage from the brain to increase the absorption of cerebrospinal fluid
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|
| Neurosurgical internal ventricular shunt | Procedure | 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 |
|