Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions

Evaluation of Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions

It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to estimate the following :

1. Intraoperative judgement of lesions excision, residual parts, visualization and operative corridor pre and after endoscope introduction.
2. Post-operative tumor control confirmed comparison between pre and postoperative MRI.
3. Postoperative complications, advantages and disadvantages compared with these when use pure microscopic excision from the literature

Study Overview

• Status: Unknown
• Conditions: Cerebellopontine Angle Tumor
• Intervention / Treatment: Device: endoscope

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: cerebellopontine angle lesions

• meningeoma.
• vestibular schwannoma.
• arachnoid cyst.
• petroclival meningeoma.

Exclusion Criteria:

• trigeminal neuralgia.
• facial neuralgia.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formerly Arm Label	Device: endoscope; It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative residual tumor	post operative MRI will be done and will be compared with the preoperative one to determine if complete excision was done or if there is residual parts	1 week

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neurilemmoma; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neuroma, Acoustic
• Other Study ID Numbers: Easpost fossa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No