Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt

March 30, 2024 updated by: Omar Mahmoud Abdellah, Sohag University
The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebrospinal fluid shunting remains the most common line of treatment for hydrocephalus. Endoscopic third ventriculostomy (ETV) is an alternative to cerebrospinal fluid (CSF) shunting that is potentially favorable due to the lack of implanted hardware. Most previous studies of ETV have focused on its role as an initial treatment for hydrocephalus and on comparing ETV with CSF shunting. However ,some patients who have previously been treated with a CSF shunt then developed malfunction are candidate for ETV.

The ETV Success Score (ETVSS) is the most widely used scale to estimate the likelihood of ETV success for a given patient .

Although the age of the patient is the most important component of the ETVSS, history of previous treatment with a shunt is also included in the model. According to the ETVSS, previous shunting reduces the likelihood of ETV success by approximately 10%.

There have been numerous previous studies of ETV in patients with a history of a CSF shunt (post shunt ETV), reporting success rates from 50% to 80% . Two review articles also covered this topic, one of which reported ETV success by meta-analysis in 68% of 519 pooled patients .

Most patients with shunt malfunction and or infection are treated with revision procedures, but ETV can be used as an alternative treatment in such cases .The role of endoscopic management of hydrocephalus in shunt malfunction was not investigated extensively so far.

There are several studies which have considered ETV as the main treatment of hydrocephalus inpatients with shunt failure.

Therefore, this is an attractive topic in neurosurgery especially in pediatric neurosurgery that can work and make a different kind of studies to explore the role of ETV for shunt failure.

The goal of the current study was to present our experience with endoscopic third ventriculostomy for management of shunt malfunction.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: endoscopic third ventriculostomy
endoscopic third ventriculostomy in patients with malfunctioning ventriculoperitoneal shunt
Device: Endoscopic third ventriculostomy
role of endoscopic third ventriculostomy in management of malfunctioning ventriculoperitoneal shunt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Coma Scale (GCS)
Time Frame: base line
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 )
Time Frame: base line
clinical symptoms improvement this Score has values between 0 and 10, 0 being the best and 10 being the worst
base line
visual acuity
Time Frame: base line
clinical symptoms improvement
base line

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiological CT brain and or MRI brain
Time Frame: base line
CT brain and or MRI brain
base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 5, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 30, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-02-05MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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