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Not yet recruiting NCT06664372

Insertion of Frontal Ventricular Catheter of VP Shunt in Congenital Hydrocephalus Guided by Trans Fontanelle Ultrasound

No phase Interventional Ventriculoperitoneal Shunt Trans Fontanelle US Congenital Hydrocephalus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trans fontanelle US Guided VP Shunt.
Who it may be relevant to
Registry conditions: Ventriculoperitoneal Shunt, Trans Fontanelle US, Congenital Hydrocephalus. Basic parameters: 5 Days — 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The Aim of This Study Is To Evaluate The Role Of Ultrasound In Decreasing Rate Of Proximal Obstruction In Frontal VP Shunt

Detailed description

Congenital Hydrocephalus is a very common congenital anomalie known as the abnormal accumulation of csf in the ventricles and subarachnoid spaces under high tension due to imbalance between synthesis and absorption of csf , The incidence of congenital hydrocephalus is higher in low income country than in high income countries Treatment options for hydrocephalus are multiple but the most common treatment option world wide is VP Shunt . Although, VP Shunt still has a high rate of failure as revisions are required in 30% - 40% of cases In Vp shunt insertion , the placement of ventricular catheter is done mainly by free hand technique but recently The trans fontanelle ultrasound guided placement of ventricular catheter become a standard technique in multiple centers The free hand technique has low accuracy rate in proper intraventricular placement of the proximal catheter than the ultrasound guided technique . On the other hand , the use of intra operative ultrasound can visualize the anatomy of lateral ventricles and choroid plexus which makes the placement of ventricular catheter more accurate than the blind free hand technique So we are aiming in this study to highlight the efficacy of ultrasound guided placement of ventricular catheter of the frontal shunt in decreasing the rate of proximal catheter obstruction and we choose the frontal shunt because it has an advantage over the occipital in rate of revisions as it has a lower rate

Interventions

  • Procedure Trans fontanelle US Guided VP Shunt
    Insertion of proximal VP shunt catheter by trans fontanelle US

Primary outcome measures

  • Rate Of Proximal Revisions In Frontal Shunt [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • patients who are diagnosed with congenital Hydrocephalus
  • age of patients : < 2 years with patent Anterior Fontanelle
  • Not operated with frontal shunt before

Exclusion criteria

  • patients who are diagnosed with congenital Hydrocephalus
  • age of patients : < 2 years with patent Anterior Fontanelle
  • Not operated with frontal shunt before

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Wang Z, Zhang Y, Hu F, Ding J, Wang X. Pathogenesis and pathophysiology of idiopathic normal pressure hydrocephalus. CNS Neurosci Ther. 2020 Dec;26(12):1230-1240. doi: 10.1111/cns.13526. Epub 2020 Nov 26. PMID 33242372
  • Sarikaya-Seiwert S, Schievelkamp AH, Born M, Wispel C, Haberl H, Shabo E. The impact of real-time ultrasound guidance on ventricular catheter placement in cerebrospinal fluid shunts - a single-center study. Ultraschall Med. 2025 Apr;46(2):170-176. doi: 10.1055/a-2352-9404. Epub 2024 Jun 25. PMID 38917967
  • Kullmann M, Khachatryan M, Schuhmann MU. Ultrasound-guided placement of ventricular catheters in first-time pediatric VP shunt surgery. Childs Nerv Syst. 2018 Mar;34(3):465-471. doi: 10.1007/s00381-017-3660-2. Epub 2017 Nov 22. PMID 29167995

Identifiers

NCT: NCT06664372 · Transfontanelle US vp shunt

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗