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临床试验/NCT01901510
NCT01901510已完成1 期

Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
21
试验地点
1
主要终点
Dose of indigo carmine needed to provide adequate chromoendoscopy of the right sided colon

研究概览

简要总结

This study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. It then will use this adequate staining concentration of Indigo Carmine to study whether this dye will increase the detection of polyps during colonoscopy.

详细描述

Colon cancer occurs in 5% of the US population. Currently colon cancer screening is recommended at the age of 50 years old for all patients who are at average risk. Colonoscopy is considered the gold standard test for colon cancer screening. This is partly because colonoscopy not only can detect polyps which are cancer precursors but also can remove them, and thereby detecting cancer and its precursors and preventing cancer. Unfortunately recent data suggest that colonoscopy can miss a significant percentage of polyps, especially on the right side of the colon. It is thought that one of the major reasons for missing polyps in the right side of the colon is the fact that they are flat or sessile serrated adenoma, both of which are more difficult than protruding polyps to identify with ordinary colon preparation and colonoscopes. Chromoendoscopy is the application of dye during colonoscopy to enhance detection of polyps. It has been shown that it improves the detection of polyps and thus has the potential of improving the performance of colonoscopy and increasing the detection of these difficult to detect polyps. It is however cumbersome and time consuming, which has discouraged its use. Indigo carmine, one commonly used dye, is actually FDA approved as a food colorant and can be consumed orally. It is minimally absorbed. In addition it is used intravenously for diagnosis of injuries of the urinary system because it is very rapidly excreted by the kidneys. The investigators believe that taking it orally will be well tolerated, and that any of the dye that is absorbed will be rapidly excreted by the kidneys and thus quickly eliminated without any side effects. Effective staining of the colon with indigo carmine and increased detection of polyps could change the current standard of care for screening for colon cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

chromoendoscopy

Active Comparator

The intervention arm will have Indigo carmine added to the colonic preperation to perform chromoendoscopy

干预措施: Chromoendoscopy (Indigo Carmine) (Drug)

Control

Other

The control arm will have minimal Indigo carmine added to the colonic prep in a concentration which will not be enough to perform chromoendoscopy

干预措施: Control (Other)

结局指标

主要结局

Dose of indigo carmine needed to provide adequate chromoendoscopy of the right sided colon

时间窗: 24 hours

The dose in Indigo Carmine in mg per 1/8 - 1/2 gallon needed to provide adequate staining of the cecum and ascending colon.

次要结局

  • Cecal intubation rate(24 hours)
  • Time to cecal intubation(24 hours)
  • Withdrawal time(24 hours)
  • Quality of bowel preparation(24 hours)
  • Patient tolerance of indigo carmine solution(30 days)
  • Quality of staining of the entire colon(24 hours)
  • Total number of sessile serrated adenoma detected(2 weeks)
  • Adenoma detection rate(2 weeks)
  • Total number of non rectal serrated polyps detected(2 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

M. Edwyn Harrison

PI

Mayo Clinic

研究点 (1)

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