Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Lesions detected
研究概览
简要总结
Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI
详细描述
Single-blind (patient) randomized study to compare detection of neoplastic lesions between chromoendoscopy and NBI.
Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to usual clinical criteria will be included. The endoscopic procedure is similar to the one usually performed. All patients will undergo colonoscopy according to the usual procedure, with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the faecal remains will be thoroughly washed.
Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1% methylene blue or New generation NBI with Near focus.
Biopsies will be taken of all those lesions detected, instead of random biopsies.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy
排除标准
- •Patients who are not trained to understand the nature of the study, the procedures to be followed or are not able to sign an informed consent
- •Known allergy or intolerance to methylene blue
- •Pregnant or lactating women
- •Personal history of colorectal cancer
- •Ulcerative colitis active more than 20 cm from the anal verge
- •Patients with known G6PD deficiency
- •Severe kidney failure
研究组 & 干预措施
Virtual Chromoendoscopy with NBI with HQ190 endoscopes
Intubation is done with normal white light. Once the cecum is reached, the removal will be done in NBI mode
干预措施: Chromoendoscopy (Procedure)
Chromoendoscopy with methylene blue 0.1%
Once the cecum is reached, a spray catheter is introduced through the working channel and the dye, a 0.1% methylene blue solution, is applied.
干预措施: Chromoendoscopy (Procedure)
结局指标
主要结局
Lesions detected
时间窗: Baseline
Total number of IBD dysplastic lesions detected by the use of NBI virtual chromoendoscopy versus conventional chromoendoscopy
次要结局
- Total endoscopy time(Baseline)
- Ratio of neoplastic lesions/total lesions(Baseline)
- Near Focus ability(Baseline)
- Non-dysplastic lesions(Baseline)
- Detection rate of dysplastic lesions(Baseline)
- Number of biopsies(Baseline)
- Removal time(Baseline)
研究者
María Dolores Martín Arranz, PhD
Principal Investigator
Hospital Universitario La Paz