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临床试验/NCT02282540
NCT02282540已完成不适用

Novel Imaging of the Eustachian Tube; Patient Study

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Extent of contrast medium passage through the Eustachian tube

研究概览

简要总结

The purpose of the study is to establish wether a contrast medium applied to the middle ear can be used to diagnose pathology in the auditory tube. We will examine patients with and without middle ear disease with CT after the application of an iodine based contrast medium.

详细描述

Introduction Dysfunction in the auditory tube / Eustachian tube (ET) is a frequent problem that may cause a series of middle ear conditions. Middle ear atelectasis, retraction of the tympanic membrane, in some cases "retraction pocket type-cholesteatoma" (5), chronic otitis, perforation of the tympanic membrane and conductive hearing loss due to poor middle ear ventilation are all associated with ET-dysfunction. The ET consists of two parts, the mobile cartilaginous part medially, and the fixated bony part laterally. The bony part is demarcated by thin bony walls and situated in the close proximity of vulnerable anatomical structures, while the cartilaginous part is supported by parapharyngeal soft tissue. Recent years, a new treatment procedure of ET balloon dilation has emerged. Restoration of ET function has offered a new approach for this large group of patients with great reduction of symptoms and secondary middle ear disease.

Only the cartilaginous part of the ET is accessible for treatment procedures. We also know that 20% of the patients dilated do not respond to dilation, and relapse of middle ear disease occurs (2). At present, no diagnostic procedure can distinguish between later responders and non-responders to dilation. Therefore, level diagnostics of obstruction and possibly identification of other discriminating parameters are important. Computer tomography (CT) is considered necessary before any type of tube intervention, mainly to exclude obstruction in the bony part of the tube or identification of any other pathoanatomical condition to contraindicate balloon dilatation. Visualisation of obstructions in the cartilaginous part is not possible with today's methods. Nor does the method provide any information on tube function.

There is a need for better diagnostic imaging of the ET. In this project we plan to develop a method for contrast medium application to the ET via the middle ear followed by CT imaging. The purpose is to tell whether the ET is open or on which level it is obstructed. So far some publications have showed that contrast media can pass through the ET (6,7,8), but no systematic trials have been published, clarifying the potential of the method.

We have recently conducted studies on temporal bone specimens from human cadavers and on 8 living rabbits. Results from these studies are not yet published, but our hypotheses are supported that the method for ET visualisation is feasible, safe, and that contrast media passes unhindered through a normal ET after application in the middle ear (6,7,8).

Hence the next step of the trial is to explore whether the method provides new information in human subjects with and without tube dysfunction.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years old Referred to ENT clinic at Rikshospitalet for evaluation and treatment of OME, tympanic membrane peroration or tympanic membrane retraction Dysfunction of the ET is suspected by the ENT surgeon The patient is a candidate for balloon dilation of the ET

排除标准

  • Previous serious allergic reaction to iodine based contrast medium Increased risk of bleeding Serious heart disease Diabetes I Previous ENT-surgery (t-tubes excluded) Middle ear disease, which requires other type of treatment Chronic rhino sinusitis or nasal polyposis Pregnancy

研究组 & 干预措施

Iodixanol to the Eustachian tube

Experimental

Iodixanol contrast medium diluted with NaCl to 20% into the tympanostomy tube while the patient lies on his / her back with the head slightly turned to the opposite side. After 10 minutes the CT examination will be conducted using 200 mA and 120 kV.

干预措施: Iodixanol to the Eustachian tube (Procedure)

结局指标

主要结局

Extent of contrast medium passage through the Eustachian tube

时间窗: 10 minutes after contrast medium application

CT-imaging to assess contrast enhancement of the ET or pharyngeal space. Either of four alternatives is possible: 1. Contrast enhancement of the pharyngeal space. 2. Contrast enhancement of the ET on the oral side of the isthmus 3. Contrast enhancement of the bony part of the ET, but not passed the isthmus 4. No contrast enhancement of the ET

次要结局

  • Local side effects of contrast medium application(4 weeks)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedicte Falkenberg-Jensen

MD

Oslo University Hospital

研究点 (2)

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