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临床试验/NCT01882205
NCT01882205招募中不适用

Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i.

Universitaire Ziekenhuizen KU Leuven9 个研究点 分布在 4 个国家目标入组 402 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
402
试验地点
9
主要终点
The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy

研究概览

简要总结

The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Until today, official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely based on consensus during expert opinion meetings rather than evidence based. Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic imaging techniques.

Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The first studies with NBI showed that the additional value of NBI in the detection of neoplastic lesions is comparable to chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is achieved via the use of post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-scan system also allows post hoc modification of the images. On the one hand, surface enhancement enables to better highlight mucosal changes. Spectral modification allows to apply different modes in analogy with to FICE system.

These new imaging techniques have a theoretical advantage which is extendedly used for sales purposes but has however so far not been proven in ulcerative colitis patients. We want to test their clinical use in the screening for neoplastic lesions in patients with long standing ulcerative colitis.

详细描述

The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Surveillance endoscopies are advised 8 to 10 years after the diagnosis of ulcerative colitis. The first decade every 3 years, the second decade every 2 years and thereafter every year Until today, most official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 random biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion using standard white light endoscopy.

These guidelines are merely based on consensus during expert opinion meetings rather than evidence based.

However, some studies have shown that the sensitivity for the detection of dysplasia during colonoscopy in patients with ulcerative colitis can significantly be enhanced by using chromo-endoscopy. These studies used methylene blue or indigo carmine as a contrast agent with or without high magnification endoscopy. Chromo-endoscopy guided targeted biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. It was therefore concluded that colonoscopy with chromo-endoscopy guided biopsies is more efficient and cost saving. Chromo-endoscopy with targeted biopsies is an alternative to white light endoscopy with random biopsies every 10cm. The European Crohn and Colitis association now suggests that the use of methylene blue or indigo carmine chromoendoscopy is an alternative to random biopsies for appropriately trained endoscopists and is superior to random biopsies in the detection rate of neoplastic lesions In this study we want to compare chromoendoscopy with targeted biopsies as the gold standard with new new endoscopic image techniques called virtual chromoendoscopy.

From 2005 new endoscopic imaging modalities have been commercialized and are now generally available to gastroenterologists. They all claim a theoretical advantage in comparison to standard white light high resolution video endoscopy. These new techniques are called virtual chromoendoscopy (VC). There are three different systems developed by the three major competitors of endoscopic equipment: Olympus, Pentax and Fujinon.

Narrow-Band Imaging (NBI) is developed by Olympus inc. and selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The intensity of the blue bandwidth is also enhanced. This leads to a more superficial penetration of the emitted light into the mucosa of the intestine and enhancement of more superficial structures (e.g. irregularities, small flat lesions or polyps) and small superficial mucosal vessels (indicative of neoplasia).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with longstanding ulcerative colitis ( 8 years after diagnosis or pancolitis and 10 years after diagnosis of left-sided colitis)
  • Signed informed consent form
  • Previous surveillance endoscopy > 1 year

排除标准

  • Active ulcerative colitis, > 20 cm from the margo ani
  • Personal history of colorectal cancer
  • Allergy or intolerance to methylene blue
  • Refusing or incapable to agree with informed consent
  • Age younger than 18 years
  • Pregnant women

结局指标

主要结局

The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy

时间窗: The primary endpoint can be assessed when pathology results are available : 2 weeks after endoscopy

The primary endpoint will be assessed in three subgroups comparing : 1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2\) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3\) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.

次要结局

  • Duration of total endoscopic procedure time and of endoscopic procedure time during retraction for each technique.(The endpoint can be assessed immediately after the endoscopy.)
  • The difference in neoplasia detection rate (i.e. the number of patients with at least one neoplastic lesion) between chromoendoscopy and virtual chromoendoscopy.(The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy)
  • The difference in the ratio number of neoplastic lesions/ total number of lesions between chromoendoscopy and virtual chromoendoscopy(The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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