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临床试验/NCT03261726
NCT03261726撤回不适用

Maintaining Cochlear Patency After VIIIth Nerve Surgery

Henry Ford Health System2 个研究点 分布在 1 个国家开始时间: 2017年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events related to implanted insertion electrode

时间窗: One year postoperatively

Office visits and MRI monitoring: 1. 2 - 3 weeks after surgery: Routine post-operative visit for wound care. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. 2. 3 - 4 months after surgery: Monitoring MRI with and without contrast of the inner ear/internal auditory canals with routine post-operative visit. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images. 3. Study Endpoint: 1 year after surgery. Repeat MRI with and without contrast of the inner ear/internal auditory canals. I. Document integrity and appearance of the eardrum. II. Document wound integrity and appearance. III. Document appearance of the cochlea on heavily T2-weighted images.

次要结局

  • Presence or absence of fluid in the cochlea(3- 4 months and 1 year after tumor removal and implantation of the insertion electrode)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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