跳至主要内容
临床试验/NCT03351257
NCT03351257Unknown不适用

Linked Color Imaging vs White-light Colonoscopy in the Characterization of Small and Diminutive Colon Polyps

Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
the accuracy of predicted in vivo polyp histology

研究概览

简要总结

Colorectal cancer is a maior cause of morbidity and mortality worldwide.Colonoscopy and removal of all adenomas is the most efficient method to prevent colorectal cancer.The most colorectal polyps detected are small(<10mm) and diminutive(≦5mm) during colonoscopy.At that size,the are overwhelmingly hyperplastic or adenomatous,and rarely harbour high-grade dysplasia,cancer or sessile serrated adenoma/polyp.Traditional white-light endoscopy cannot reliably distinguish between small adenomatous and hyperplastic polyps,thus,real-time recognition of the polyp histology during colonoscopy has the potential to minimize both the costs and complications associated with endoscopic biopsy and polpectomy.Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of magnifying blue laser imaging(BLI) technology. it is easier to recognize a slight difference in color of the mucosa. This is a study to investigate the impact of Linked color imaging endoscopes on the in vivo histology prediction of colonic polyps.

详细描述

This is a prospective study comparing the accuracy of linked color imaging(LCI) and standard white light colonoscopes in the diagnosis of small and diminutive colorectal polyps.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 1.ability to provide written informed consent and undergoing colonoscopy. 2.The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up.
  • 3.detection and retrieval for histologic examination of at least one polyp< 10mm in size and/or 5mm in size

排除标准

  • Patients were previous colon resection
  • Patients were a diagnosis of inflammatory bowel disease,familial polyp syndromes or poor bowel preparation
  • suspected chronic stricture potentially precluding complete colonoscopy
  • Patients had polypectomy or had coagulopathy/thrombocytopenia
  • Patients had diverticulitis or toxic megacolon;previous radiation therapy to the abdomen or pelvis;severe cardiovascular,pulmonary,liver,or renal disease;and coagulation disorders or use of anticoagulants.
  • all of polyps could influence surface pattern or/and color assessment

结局指标

主要结局

the accuracy of predicted in vivo polyp histology

时间窗: 5 months

the accuracy of predicted in vivo polyp histology

次要结局

  • specificity(5 months)
  • Sensitivity(5 months)

研究者

发起方
Affiliated Hospital to Academy of Military Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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