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临床试验/NCT02570516
NCT02570516已完成不适用

Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.

Assistance Publique - Hôpitaux de Paris14 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
14
主要终点
Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)

研究概览

简要总结

This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome

详细描述

Chromoendoscopy using indigo carmine dye is recommended every 1 to 2 years in patients having Lynch Syndrome (LS). However, it is a time-consuming procedure, requiring a prior learning and has an additional cost, the reason why it is not yet systematically practiced in all endoscopy centers. The "Narrow Band Imaging" (NBI) is a recent virtual chromoendoscopy technique using optical filters at the light source of the endoscope to highlight the vascular structures of the mucosa by pressing a button. NBI is currently used to better characterize dysplasia lesions in the esophageal, gastric, and colon mucosa. A new generation (3rd generation) of NBI is currently available on some endoscopes, it can deliver more brightness and contrast, and could allow for better detection of flat lesions. Until today, no study has directly compared colonic chromoendoscopy with Indigo carmine to virtual chromoendoscopy with NBI (3rd generation) in LS patients. The hypothesis that this research aims to verify is that the new generation NBI system might do at least as well as indigo carmine in colonic adenoma detection in LS. This study aims to compare colonoscopy with virtual chromoendoscopy using 3rd generation NBI system to chromoendoscopy with indigo carmine in LS patients, in a back-to-back, prospective non inferiority design, in which all patients will have both techniques in the following order: NBI first followed by Indigo carmine.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lynch Syndrome with an identified mutation in one of the genes MutL Homolog 1 (MLH1), MutL Homolog 2 (MLH2), MutS homolog6 (MSH6), PMS2 or epithelial cellular adhesion molecule (EpCAM)
  • Age between 18 and 80
  • Indication of a screening colonoscopy

排除标准

  • Any sign of intestinal occlusion contra-indicating bowel preparation
  • History of total or subtotal colectomy
  • Any serious medical condition contra-indicating colonoscopy under general anesthesia
  • Pregnant or breast feeding women
  • Any coagulation disorder contra-indicating biopsies or endoscopic resections
  • Any history of hypersensitivity to indigo carmine
  • Adults subject to a legal protection measure (guardianship or curatorship)

研究组 & 干预措施

Indigo carmine colonoscopy

Active Comparator

Colonoscopy using indigo carmine is performed in second place

干预措施: Colonoscopy (Procedure)

NBI colonoscopy

Experimental

Colonoscopy using NBI is performed in first place

干预措施: Colonoscopy (Procedure)

结局指标

主要结局

Number of adenomas and / or adenocarcinoma detected during each procedure (NBI vs Indigo carmine)

时间窗: procedure time

The adenoma detection rate (number of adenoma and/or adenocarcinoma) of NBI and the additional adenoma detection rate of indigo carmine.

次要结局

  • All neoplastic lesions detected during colonoscopy(procedure time)
  • Number of subject with adverse events as mesure of safety.(One month after colonoscopy)
  • Duration of each procedure (NBI vs Indigo carmine)(Procedure time)
  • Cost of each procedure (NBI vs Indigo carmine)(Procedure time)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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