A Prospective Randomized Clinical Trial to Assess the Utility of Advanced Endoscopic Imaging and the Impact of New Technologies on Quality in Colonic Examinations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of innovative colonoscopy
研究概览
简要总结
The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice.
The important elements of this evaluation are:
- Evaluation of the character of neoplastic lesions in the colon based on different imaging techniques
- Verification of the endoscopic image with histopathologic descriptions
- Establishing the type of the lesion on the basis of Kudo and NICE classifications
- Comparison of the result of histopathological examination with the macroscopic type of the lesion
- Determination of the most advanced lesions (MAL)
- Comparison of the cecal intubation time
- Evaluation of the type of anesthesia used during colonoscopy
- Subjective assessment of the severity of pain according to VAS (visual analogue scale)
- Comparison of the accuracy of the location of lesions on the basis of endoscopic navigation
- Comparison of the total examination time
- Comparison of adenoma detection rate
详细描述
A total of 400 consecutive patients undergoing unsedated colonoscopy as a part of a national colorectal cancer screening program will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions according. to Kudo and NICE classification. Endoscopic biopsy samples will be taken from all lesions and in vivo endoscopic diagnosis will be compared with final histopathological result. Thus, sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, cecal intubation rate and pain intensity (VAS) will be determined. This study will help to establish whether advanced imaging technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •no previous abdominal surgery
- •no colonoscopy during last 10 years
排除标准
- •age < 40 and > 65 years
- •large bowel resection in history
- •colonoscopy performed during last 10 years
- •contraindications for general anaesthesia
- •ASA > IV
- •pregnancy
- •confirmed neoplastic disease
- •cirrhosis (Child B or C) or ascites
- •immunosuppressive therapy or steroids intake
- •malabsorption syndrome
- •GI neoplastic disease
结局指标
主要结局
Diagnostic accuracy of innovative colonoscopy
时间窗: 1 year
Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to NICE and Kudo classification during colonoscopy and results will be compared with histologic examination.
次要结局
- Pain intensity (VAS scale)(immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure)
- Total examination time(8-20 minutes)
- Cecal intubation time(5-15 minutes)
研究者
Miroslaw Szura
Associate Professor
Jagiellonian University