Chromoscopy-guided Endomicroscopy With the PENTAX EC-3870CIFK / EC-3870CILK Confocal Colonoscopes for the Detection of Intraepithelial Neoplasias in Subjects With Long Standing Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 182
- 试验地点
- 5
- 主要终点
- The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN
研究概览
简要总结
This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.
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
- 否
入选标准
- •Written informed consent must be available before any trial-related procedures
- •Male and female patients aged 18 years and older
- •Clinically and histologically verified UC
- •Duration or Colitis ulcerosa >8 years (date of first diagnosis)
- •Colitis Activity Index ≤ 8
- •Activity index of Truelove and Witts: mild
- •Ability of subject to understand character and individual consequences of clinical trial
- •For women with childbearing potential, adequate contraception.
排除标准
- •Known intraepithelial neoplasia or colorectal cancer
- •Coagulopathy (Prothrombin time <50% of control, Partial thromboplastin time >50 s)
- •Impaired renal function (Creatinine >1.2 mg/dL)
- •Pregnancy or breast feeding
- •Inability to obtain informed consent
- •Active GI Bleeding
- •Known allergy to methylene blue or fluorescein
- •Participation in other clinical trials within the last 4 weeks
研究组 & 干预措施
A
Chromoscopy-guided endomicroscopy with targeted biopsies
干预措施: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes (Device)
B
Standard endoscopy with random and targeted biopsies
干预措施: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes (Device)
结局指标
主要结局
The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN
时间窗: Day 1 (colonoscopy)
次要结局
- Efficacy of chromoscopy-guided endomicroscopy in the detection of lesions and in the reduction of the number of biopsies. Time needed for the examination will be measured and compared between the two groups.(Day 1 (colonoscopy))
研究者
Annette Weissmann
Trial Coordinator
PENTAX Europe GmbH