Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt

NCT06341946 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-02-05MD
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV).

Conditions

Hydrocephalus; Shunt Malfunction

Keywords

endoscopic third ventriculostomy

Outcome Measures

Primary Outcomes (3)

• Glasgow Coma Scale (GCS)

  clinical symptoms improvement this Score has values between 3 and 15, 3 being the worst and 15 being the highest

  base line

• visual analogue scale( VAS )

  clinical symptoms improvement this Score has values between 0 and 10, 0 being the best and 10 being the worst

  base line

• visual acuity

  clinical symptoms improvement

  base line

Secondary Outcomes (1)

• radiological CT brain and or MRI brain

  base line

Study Arms (1)

endoscopic third ventriculostomy

OTHER

endoscopic third ventriculostomy in patients with malfunctioning ventriculoperitoneal shunt

Device: Endoscopic third ventriculostomy

Interventions

Endoscopic third ventriculostomy DEVICE

role of endoscopic third ventriculostomy in management of malfunctioning ventriculoperitoneal shunt

endoscopic third ventriculostomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with malfunctioning VP shunt will be included in this study.

You may not qualify if:

• Patients with contraindications for endoscopic procedure such as intracranial infection or bleeding disorders
• Previous unsuccessful attempts of endoscopic third ventriculostomy.
• Active infection or inflammation in the central nervous system.
• Recent history of intracranial hemorrhage.
• Medically unfit for surgery.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (9)

• Kulkarni AV, Drake JM, Kestle JR, Mallucci CL, Sgouros S, Constantini S; Canadian Pediatric Neurosurgery Study Group. Predicting who will benefit from endoscopic third ventriculostomy compared with shunt insertion in childhood hydrocephalus using the ETV Success Score. J Neurosurg Pediatr. 2010 Oct;6(4):310-5. doi: 10.3171/2010.8.PEDS103.

  PMID: 20887100 BACKGROUND

• Kulkarni AV, Riva-Cambrin J, Browd SR. Use of the ETV Success Score to explain the variation in reported endoscopic third ventriculostomy success rates among published case series of childhood hydrocephalus. J Neurosurg Pediatr. 2011 Feb;7(2):143-6. doi: 10.3171/2010.11.PEDS10296.

  PMID: 21284458 BACKGROUND

• Furtado LMF, da Costa Val Filho JA, Holliday JB, da Silva Costa J, de Matos MA, Nascimento VAM, Ramos Cavalcanti T. Endoscopic third ventriculostomy in patients with myelomeningocele after shunt failure. Childs Nerv Syst. 2020 Dec;36(12):3047-3052. doi: 10.1007/s00381-020-04596-5. Epub 2020 Apr 4.

  PMID: 32248278 BACKGROUND

• Takeshige N, Uchikado H, Nakashima D, Negoto T, Nagase S, Yoshitomi M, Sakata K, Morioka M. Endoscopic third ventriculostomy for myelomeningocele-related hydrocephalus after shunt failure: Long-term outcome in a series of 8 patients. Clin Neurol Neurosurg. 2021 Feb;201:106406. doi: 10.1016/j.clineuro.2020.106406. Epub 2020 Dec 4.

  PMID: 33341457 BACKGROUND

• Chhun V, Sacko O, Boetto S, Roux FE. Third Ventriculocisternostomy for Shunt Failure. World Neurosurg. 2015 Jun;83(6):970-5. doi: 10.1016/j.wneu.2015.01.058. Epub 2015 Mar 13.

  PMID: 25772610 BACKGROUND

• Irrinki RNNS, Bawa M, Hegde S, Chhabra R, Gupta V, Gupta SK. Functional and Radiological Parameters to Assess Outcome of Endoscopic Third Ventriculostomy in Shunt Failure Patients. J Pediatr Neurosci. 2019 Apr-Jun;14(2):65-69. doi: 10.4103/jpn.JPN_31_19.

  PMID: 31516622 BACKGROUND

• Talamonti G, Nichelatti M, Picano M, Marcati E, D'Aliberti G, Cenzato M. Endoscopic Third Ventriculostomy in Cases of Ventriculoperitoneal Shunt Malfunction: Does Shunt Duration Play a Role? World Neurosurg. 2019 Jul;127:e799-e808. doi: 10.1016/j.wneu.2019.03.268. Epub 2019 Apr 4.

  PMID: 30954740 BACKGROUND

• Boschert J, Hellwig D, Krauss JK. Endoscopic third ventriculostomy for shunt dysfunction in occlusive hydrocephalus: long-term follow up and review. J Neurosurg. 2003 May;98(5):1032-9. doi: 10.3171/jns.2003.98.5.1032.

  PMID: 12744363 BACKGROUND

• Bilginer B, Oguz KK, Akalan N. Endoscopic third ventriculostomy for malfunction in previously shunted infants. Childs Nerv Syst. 2009 Jun;25(6):683-8. doi: 10.1007/s00381-008-0779-1. Epub 2008 Dec 11.

  PMID: 19082608 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Interventions

Ventriculostomy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Central Study Contacts

Omar Mahmoud Abellah, M.B.B. Ch, M.Sc

CONTACT

01114514558; omr.hassan@med.sohag.edu.eg

Roshdy Abdelaziz Elkahyat, MD, Professor of Neurosurgery

CONTACT

01223486390; roushdy.elkhayat@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: All patients with malfunctioning VP shunt will be included in this study

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 2, 2024
• Study Start: April 5, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-03