跳至主要内容
临床试验/NCT02049775
NCT02049775Unknown不适用

Utility of Narrow Band Endoscopy in Predicting Short and Long Term Risk of Relapse in Patients With Quiescent Ulcerative Colitis

The Leeds Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家开始时间: 2013年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
试验地点
2
主要终点
Narrow band imaging (NBI)

研究概览

简要总结

Ulcerative colitis (UC) is a chronic inflammatory condition of unknown aetiology, characterized by a diffuse confluent mucosal inflammation of the colon starting from the rectum with a relapsing and remitting course. Conventional endoscopy was thought to be a reliable parameter of disease activity, but microscopic inflammation can persist despite normal mucosal findings. Histologically detectable inflammation is associated with a greater risk of subsequent relapse. A flare in UC activity is difficult to predict, but a simple, easily measured biological marker of relapse would be important in guiding the most appropriate therapy.

Recent technological advances in fiber optics, light sources, detectors, and molecular biology have stimulated development of numerous optical methods that promise to significantly improve our ability to evaluate human epithelium in vivo. These methods, collectively termed "optical biopsy," are nondestructive in situ assays of mucosal histopathology using light that can provide instantaneous tissue assessment. Narrow band imaging (NBI) is a novel technique that enhances the diagnostic capability of endoscopes in characterising tissues by using filters in a redgreenblue (RGB) sequential illumination system. This results in improved mucosal contrast and detail.

UC always involves the distal colon and activity is usually greatest in rectosigmoid area. This makes evaluation of the rectum and sigmoid an attractive marker in patients with UC. Unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be affected by systemic disease and would be acceptable test for patients and physicians.

We plan to evaluate THE rectosigmoid mucosa in patients with UC by flexible endoscope using both white light and NBI endoscopy. These patients will be followed by for one year or until they relapse, whichever comes first. The aim of our study is to develop endoscopic biomarkers to predict relapse in acute and quiescent UC.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients referred for lower gastrointestinal endoscopy procedure will be recruited.
  • Any age (1885 years), gender or ethnic background
  • Able and willing to give an informed consent

排除标准

  • Patients known to be intolerant to endoscopy.
  • Patients with severe lifethreatening comorbidity as judged by the investigator.
  • Patients on therapy with anticoagulation that may preclude taking any biopsies
  • Pregnant women or breast feeding mothers
  • Patient with toxic megacolon
  • patients on medications known to cause bowel inflammation.

结局指标

主要结局

Narrow band imaging (NBI)

时间窗: up to 2 years

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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