- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ibraheem Ahmed Yosuf, Master degree
- Telefonnummer: +20 01118440865
- E-post: Ebrahim.Ahmed@aun.edu.eg
Studieorter
-
-
Asyut Governorate
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Asyut, Asyut Governorate, Egypten, 71515
- Assuit University Hospital
-
Kontakt:
- Ibraheem Ahmed Yosuf, Master degree
- Telefonnummer: +20 01118440865
- E-post: Ebrahim.Ahmed@aun.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Combined ETV & CPC
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
2. shunt-free survival
Tidsram: 2 years minimumly
|
The period that patients underwent ETV & CPC stays without need for shunt
|
2 years minimumly
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in health care burden of paediatric hydrocephalus
Tidsram: 2 years minimumly
|
2 years minimumly
|
|
Change in rate of hospital admissions
Tidsram: 2 years minimumly
|
2 years minimumly
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ETV & CPC in hydrocephalus
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
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