跳至主要内容
临床试验/NCT03274115
NCT03274115已完成不适用

BLI (Blue Light Imaging) Application for the Histological Characterization of Colorectal Polyps

Valduce Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年7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
600
试验地点
2
主要终点
Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology

研究概览

简要总结

The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new system for image-enhanced endoscopy using laser light, that is incorporated in the last generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by excitation.This system should enhance the microvascular pattern of superficial lesions, making the histological prediction easier.

Aim of the study is to compare the accuracy of white light and BLI systems in real-time histology prediction of colonic polyps.

For this purpose all colonscopies will be performed in a standard fashion using white light. When a polyps <10mm in size will be identified, patients will be randomized in two groups. In the Group 1 (White Light Grroup), all polyps <10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made by means of white light. In the Group 2 (BLI Group) , all polyps <10mm in size will be evaluated with BLI and scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface pattern. The level of endoscopist's confidence in predicting histology (high or low confidence) for any polyp will be also recorded.

Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative predictive values) will be calculated comparing endoscopist's prediction and pathology report, considered as reference standard in both study groups in order to evaluate the accuracy of real-time histology prediction by using BLI or white light.

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
Single (Participant)

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

  • All outpatients referred for colonoscopy

排除标准

  • inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment)
  • previous colonic resection
  • inflammatory bowel disease
  • ereditary polyposic syndromes
  • patients on antithrombotics precluding polyp resection
  • absence of informed consent
  • inpatients or patients undergoing urgent colonscopy

研究组 & 干预措施

White Light (WL)

No Intervention

White light will be used for histology prediction of colonic polyps (hyperplastic versus adenomatous).

Blue Light Imaging (BLI)

Active Comparator

Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps.

干预措施: BLI (Blue Laser Imaging) (Device)

结局指标

主要结局

Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology

时间窗: one year

Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology will be calculated comparing endoscopist's prediction with pathology result (reference standard).

次要结局

未报告次要终点

研究者

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

Franco Radaelli

MD, Head of Gastrointestinal Endoscopy Unit

Valduce Hospital

研究点 (2)

Loading locations...

相似试验