Endoscopic and Endoscopic-Assisted Microsurgery of Intraventricular Lesions

September 24, 2020 updated by: Nour Imam, Assiut University

Endoscopic and Endoscopic-Assisted Microsurgery of Intraventricular Lesions: Efficacy of Technique and Outcome Assessment

  • Assess the efficacy of the endoscope as a single tool or as an adjuvant tool to the microscope in intraventricular procedures.
  • Evaluate the limitations of the endoscope in these procedures.
  • Review the outcome of endoscopic and/or endoscopic assisted microsurgical intraventricular procedures.
  • Achieve a verdict in the long-standing controversy about the most effective, least invasive, and optimal way to resect intraventricular lesions, can the endoscope rival the surgical microscope?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lesions within the ventricular system present a challenge to neurosurgeons (1). Their deep location and proximity to eloquent neurovascular anatomy complicate surgical approach and resection (2). Microsurgery remains the gold standard for the treatment of intraventricular tumors, but microsurgical approaches are not without limitations (3). With the use of the operative microscope, most lesions of the lateral and third ventricles are accessed by a craniotomy and either a transcortical or interhemispheric transcallosal approach. These approaches are associated with brain retraction that can result in seizures, focal neurologic deficits, and cognitive impairment (1). Also with standard microsurgical techniques, complete resection is sometimes not achieved either because of nonvisualization of hidden parts of the tumor or requirement of significant retraction of the neurovascular structures which is potentially hazardous (4). The addition of the endoscope for resection of intraventricular lesions has been described and represents a minimally invasive approach that limits brain retraction and provides direct lesion visualization (1,5,6). The recent development of endoscopic instrumentation has greatly enhanced microsurgical access to the ventricular system and would allow enhanced microsurgical access, minimize the size of the transcortical corridor, and reduce brain retraction during removal of challenging intraventricular lesions performed with the surgical microscope (7). The application of the endoscope can be used in the treatment of intraventricular lesions as arachnoid cyst with intraventricular extensions, colloid cysts, biopsies and intraventricular brain tumor removal (8). Reestablishment of CSF communication pathways is also possible endoscopically when patients develop obstructive hydrocephalus due to their intraventricular pathology (1). The biggest issues when it comes to a pure endoscopic approach concern the size and extent of the lesion, possibility of complete cure or at least long-term control of the disease, and the presence of remnants that were not completely excised (8) , However, The desire for a less invasive technique and an effective surgical approach to intraventricular pathology has directed the attention of many in the neurosurgical community towards the introduction of the endoscope as an adjuvant to or even a replacement for the microscope in intraventricular surgery (5) and consequently, neuroendoscopy has grown rapidly in the last 25 years as a therapeutic modality in the treatment of intraventricular pathologies (9,10).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Nour Eldin H. M. K. Imam, Masters Degree in Neurosurgery
  • Phone Number: +201099855603
  • Email: nourimam@outlook.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PAtients with intraventricular lesions, presented to The Neurosurgery Department, At Assiut University Hospital in Assiut, Egypt

Description

Inclusion Criteria:

  • Intraventricular arachnoid cysts
  • Intraventricular colloid cysts
  • Intraventricular tumors.

Exclusion Criteria:

  • Intraventricular lesions extending outside the ventricle (exception to arachnoid cysts)
  • Patients who are unfit for any neurosurgical interventions.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early Clinical outcome using Glasgow Outcome Scale
Time Frame: Early outcome: 24 hours post-operatively.

Assessment of the post operative mortality and morbidity using:

Glasgow Outcome Scale:

  1. Death:Self-explanatory
  2. Persistent vegetative state: Coma or severe deficit rendering the patient totally dependent
  3. Severe disability: Significant neurological deficit interfering with daily activities or prevents return to employment
  4. Moderate disability:Minor neurological deficit not interfering with daily functioning or work
  5. Good recovery:Returned to the original functional level with no deficit
Early outcome: 24 hours post-operatively.
Early Clinical outcome using Modified Rankin Scale
Time Frame: Within 6 weeks after surgery.

The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients, as follows:

  • 0: No symptoms at all
  • 1: No significant disability despite symptoms; able to carry out all usual duties and activities
  • 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  • 3: Moderate disability; requiring some help, but able to walk without assistance
  • 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
  • 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  • 6: Dead
Within 6 weeks after surgery.
Late outcome assessment
Time Frame: within 6 months after surgery
Within six months, assessment of the performance of the patient with modified rankin scale.
within 6 months after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut 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 (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Intraventricular Endoscopy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug 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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