【ChiCTR-INR-16008616】比較絲裂黴素C合併支架植入術與單純黏膜瓣保留鼻內鏡下淚囊鼻腔吻合術對原發性鼻淚管阻塞的手術療效

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基本信息

登记号

ChiCTR-INR-16008616

试验状态

尚未开始

药物名称

比較絲裂黴素C合併支架

药物类型

规范名称

首次公示信息日的期

2016-06-08

临床申请受理号

靶点

适应症

原發性鼻淚管阻塞

试验通俗题目

比較絲裂黴素C合併支架植入術與單純黏膜瓣保留鼻內鏡下淚囊鼻腔吻合術對原發性鼻淚管阻塞的手術療效

试验专业题目

比較絲裂黴素C合併支架植入術與單純黏膜瓣保留鼻內鏡下淚囊鼻腔吻合術對原發性鼻淚管阻塞的手術療效

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

比較絲裂黴素C合併支架植入術與單純黏膜瓣保留鼻內鏡下淚囊鼻腔吻合術對原發性鼻淚管阻塞的手術療效.

试验分类

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试验类型

随机平行对照

试验分期

治疗新技术

随机化

Randomized

盲法

Single-blind

试验项目经费来源

Research Grants Council

试验范围

目标入组人数

340

实际入组人数

第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

Adult >=18 years old and there is no maximum age limit; Primary acquired nasolacrimal duct obstruction (PANLDO) diagnosed by lacrimal irrigation and probing, confirmed intraoperatively after incision of lacrimal sac; Informed consent for operation, randomization and recording; Compliance to follow-up and treatment.；

排除标准

Pregnancy, lactation (contraindication for topical mitomycin C); Known allergy to mitomycin, cocaine, adrenaline, steroid, silicone material; Contraindications of endonasal DCR or inability to undergo nasal endoscopy; Acute (<3 months) or non-bacterial dacryocystitis e.g. tuberculosis, fungal or parasitic; Ipsilateral canalicular disorder e.g. obstruction, canaliculitis, canaliculocele, diverticulum; Ipsilateral recurrent NLDO or any prior lacrimal intervention except punctoplasty; Ipsilateral facial paralysis despite apparent clinical recovery; Ipsilateral conditions affecting bony nasolacrimal outflow e.g. midfacial trauma/fracture42, osteoma, fibrous dysplasia and other skull-base disorders; Ipsilateral suspected or confirmed nasolacrimal or sinoorbital neoplasm 43; Ipsilateral severe ocular surface disorders e.g. ocular cicatrical pemphigoid, chemical burns, Steven Johnson Syndrome, Toxic Epidermal Necrolysis44; Conditions affecting mucosa of the nose or nasolacrimal system e.g. rhinosinusitis, Wegener’s granulomatosis, sarcoidosis45, radioactive iodide46, head & neck radiotherapy47, ipsilateral maxillectomy48, systemic chemotherapy (5-fluorouracil, docetaxel49); Ipsilateral topical antiglaucomatous or chemotherapy drops (e.g. timolol50, mitomycin C); Intraoperative false passage of Bowman probe or metal part of silicone stent; Dacryolith or intrasaccal mass.；

研究者信息

研究负责人姓名

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试验机构

Research Grants Council

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研究负责人邮编

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