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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04060810
Other study ID # grey zone hydrocephalus
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2019
Est. completion date March 2021

Study information

Verified date August 2019
Source Assiut University
Contact Mohammad Mohammad
Phone 01005663647
Email mohamed011353@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.


Description:

Hydrocephalus could be defined as disturbance of formation, flow or absorption of CSF. We encounter some challenging cases with intermittent non specific symptoms as delayed milestones and headache with concomitant imaging showing dilated ventricular system, so we find ourselves hesitating to take the decision of surgical intervention to put shunt or not, therefore MRI CSF flowmetry gives us a chance to overcome this problem. Phase contrast MR imaging is a rapid, simple and non-invasive technique which is sensitive to even small CSF flows, and can be used to evaluate CSF flow both qualitatively and quantitatively.

CSF flow measurement at the suspected level of obstruction gives reliable and reproducible results for more accurate diagnosis and can be used to guide therapeutic decisions in a more reliable manner, and follow up post treatment outcome.

With the CT and magnetic resonance imaging (MRI) techniques, it is possible to localize with accuracy the exact site of blockage of flow to CSF. Hence classification is as follows: The hydrocephalus may be due to 1) overproduction of CSF 2) obstructive 3) absorption defect. Depending on the exact aetiology, a secondary classification could be added under the following headings: 1) congenital, 2) acquired, eg; traumatic inflammatory, neoplastic, and degenerative . Bypassing the site of obstruction to CSF flow by diverting the CSF from ventricular cavity to a site where it is readily absorbed is the basic principle underlying the treatment of hydrocephalus. Extensive range of complications has been reported for shunting for hydrocephalus. They could be classified as mechanical or flow-related complications as CSF over drainage leading to subdural hematoma, subdural collections, low-pressure headaches cranial deformity, and asymmetrical drainage can lead to trapping or isolation of a part of a ventricular system. The slit ventricular syndrome is a complication related to absorption. Besides, ascites, loculations, hydrocele, perforation of the stomach, large and small bowel are also described. The success rates of shunt operation for hydrocephalus depend on the age of the patient and the reason why the shunt is needed. Generally, there is around a 50% failure rate for ventriculoperitoneal shunts.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date March 2021
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Patients with borderline hydrocephalus

- Clinically:suspicious and non specific symptoms as

- Headache

- Macrocranium

- Vomiting

- Gait instability

- Dementia

- Urine incontinence.

- delayed milestone.

- Radiologicaly: dilated ventricular system.

Exclusion Criteria:

- Documented or clinically and radiologically evident cases of hydrocephalus

- Patients known to have contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MR CSF flowmetry
MR flowmetry in grey zone hydro cephalic patients followed by ventriculoperitoneal shunt

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Algin O, Hakyemez B, Parlak M. Phase-contrast MRI and 3D-CISS versus contrast-enhanced MR cisternography on the evaluation of the aqueductal stenosis. Neuroradiology. 2010 Feb;52(2):99-108. doi: 10.1007/s00234-009-0592-x. Epub 2009 Sep 15. — View Citation

Bhatnagar V, George J, Mitra DK, Upadhyaya P. Complications of cerebrospinal fluid shunts. Indian J Pediatr. 1983 Mar-Apr;50(403):133-8. — View Citation

Brassow F, Baumann K. Volume of brain ventricles in man determined by computer tomography. Neuroradiology. 1978;16:187-9. — View Citation

Reddy GK, Bollam P, Caldito G. Long-term outcomes of ventriculoperitoneal shunt surgery in patients with hydrocephalus. World Neurosurg. 2014 Feb;81(2):404-10. doi: 10.1016/j.wneu.2013.01.096. Epub 2013 Feb 4. — View Citation

Venkataramana NK. Hydrocephalus Indian scenario - A review. J Pediatr Neurosci. 2011 Oct;6(Suppl 1):S11-22. doi: 10.4103/1817-1745.85704. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Decompressive changes in CT brain CT brain showing decompression of the ventricular system in response to ventriculoperitoneal shunt 2 months
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