- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07735936
Efficacy of Combined Endoscopic Third Ventriculostomy and Choroid Plexus Cauterization in Treatment of Hydrocephalus
Efficacy of Combined Endoscopic Third Ventriculostomy and Choroid Plexus Cauterization as Primary Treatment for Paediatric Hydrocephalus
Hydrocephalus remains one of the most common conditions encountered in neurosurgery, traditionally managed by ventriculoperitoneal (VP) shunting. Despite its effectiveness, shunt dependency is associated with certain complications including infection, obstruction, and repeated revisions, leading to increased morbidity and healthcare burden.
Over the last 70 years, cerebrospinal fluid (CSF) shunting and more recently endoscopic third ventriculostomy (ETV) have been the mainstays of hydrocephalus treatment. In recent years, choroid plexus cauterization (CPC) has re-emerged as an additional treatment strategy.
In combination with ETV, CPC increases the chances of successfully treating some cases with hydrocephalus, than ETV alone.
Endoscopic Third Ventriculostomy (ETV) has emerged as an alternative physiological treatment by creating a bypass for cerebrospinal fluid (CSF) flow. However, its success is limited in infants and in other varieties of hydrocephalus. The addition of Choroid Plexus Cauterization (CPC), which reduces CSF production, has been shown to improve outcomes when combined with ETV, particularly in younger patients.
The idea is based on the principle that ablation of the predominant source of CSF secretion within the brain, choroid plexus (CP), reduces CSF production. In addition, CPC may reduce CSF pulsatility, an effect which may be potentiated when combined with ETV, which might reduce intraventricular pulsations by serving as a pulsation absorber. These effects, in combination, may tip the balance in favour of CSF absorption and negate the need for shunting in a proportion of patients.
The combined ETV-CPC approach, popularized by Benjamin Warf, has demonstrated promising results in reducing shunt dependence, especially in resource-limited settings. However, variability in success rates persists due to differences in patient selection, etiology, and surgical expertise.
This study aims at evaluation of the efficacy of combined ETV-CPC as a primary treatment modality for hydrocephalus and to identify predictors of surgical success and failure, thereby optimizing patient selection and improving outcomes.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ibraheem Ahmed Yosuf, Master degree
- Telefonnummer: +20 01118440865
- E-post: Ebrahim.Ahmed@aun.edu.eg
Studiesteder
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Asyut Governorate
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Asyut, Asyut Governorate, Egypt, 71515
- Assuit University Hospital
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Ta kontakt med:
- Ibraheem Ahmed Yosuf, Master degree
- Telefonnummer: +20 01118440865
- E-post: Ebrahim.Ahmed@aun.edu.eg
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Children below 18 years
- Radiologically diagnosed obstructive hydrocephalus
- Late onset aqueductal stenosis cases
Exclusion Criteria:
- Communicating hydrocephalus.
- Acute interventricular haemorrhage cases
- Active infection cases
- Multilocular hydrocephalus cases
- Previous CSF diversion cases
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Combined ETV & CPC
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Using ETV & CPC in paediatric hydrocephalus will reduce Complications as CSF leak and Infection, Hospital stay, Evaluate time to failure, Compare outcomes across different hydrocephalus aetiologies and Medical care cost.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
2. shunt-free survival
Tidsramme: 2 years minimumly
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The period that patients underwent ETV & CPC stays without need for shunt
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2 years minimumly
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in health care burden of paediatric hydrocephalus
Tidsramme: 2 years minimumly
|
2 years minimumly
|
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Change in rate of hospital admissions
Tidsramme: 2 years minimumly
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2 years minimumly
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ETV & CPC in hydrocephalus
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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