Endoscopic and Endoscopic-Assisted Microsurgery of Intraventricular Lesions

• Conditions: Endoscopy in Intraventricular Lesions

• Registration Number: NCT04569201
• Lead Sponsor: Assiut University

Brief Summary

* 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?

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 Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29
• Study Start: 2020-11-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early Clinical outcome using Glasgow Outcome Scale	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 Clinical outcome using Modified Rankin Scale	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
Late outcome assessment	within 6 months after surgery	Within six months, assessment of the performance of the patient with modified rankin scale.