Clinical trial NCT03261726: Maintaining Cochlear Patency After VIIIth Nerve Surgery
Official title: Maintaining Cochlear Patency After VIIIth Nerve Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acoustic Neuroma
Labyrinthitis Ossificans
Profound Hearing Impairment
Keywords: unilateral deafness
acoustic neuroma
cochlear implant
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Med-El Corporation
First posted: 2017-08-25
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth on serial MRI scans typically lead to deafness in the affected ear over time. Radiation (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in \~80% while surgery (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small tumors, although initial hearing preservation by both modalities may fail over time. Surgical resection via the translabyrinthine approach is the safest way to remove many of these tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be required later. The incidence of this is 46% in our patients. This study seeks to determine the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant at a later time.


Eligibility criteria: Inclusion Criteria:

* patients of all ages with unilateral or bilateral acoustic neuromas who face loss of hearing in 1 ear from surgical removal via a translabyrinthine approach.
* patients do not meet criteria for conventional cochlear implantation or auditory brainstem implantation.
* tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve.
* the patient must be willing to undergo preoperative S pneumococcus immunization protocol recommended by the US CDC immunization recommendations for cochlear implant patients.

Exclusion Criteria:

* inability to preserve the auditory division of the VIIIth cranial nerve during tumor removal ossification or fibrosis of the cochlea found on preoperative imaging (CT or MRI) that precludes cochlear implantation.
* active middle ear disease.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode
timeFrame: One year postoperatively
Secondary outcomes:
measure: Presence or absence of fluid in the cochlea
timeFrame: 3- 4 months and 1 year after tumor removal and implantation of the insertion electrode
Other outcomes:
Locations:
city: Farmington Hills
country: United States
facility: The Michigan Ear Institute
state: Michigan
Study officials:
affiliation: Ascension Providence Hospital
name: Eric W Sargent, MD
role: PRINCIPAL_INVESTIGATOR
References: