Acetic Acid Colonoscopy Enhancement Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Additional serrated lesions diagnosed after acetic acid spraying
研究概览
简要总结
The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures limited to the examination of the right colon.
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. Secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results.
Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is >40 years old
- •The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- •The patient must understand and provide written consent for the procedure.
排除标准
- •Patients with a history of colonic resection;
- •Patients with inflammatory bowel disease;
- •Patients with a personal history of polyposis syndrome;
- •Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- •Patients with diverticulitis or toxic megacolon;
- •Patients with a history of radiation therapy to abdomen or pelvis;
- •Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
研究组 & 干预措施
Acetic Acid
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
干预措施: Acetic Acid (Drug)
结局指标
主要结局
Additional serrated lesions diagnosed after acetic acid spraying
时间窗: 12 months
Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes
次要结局
- Complication rate(12 months)
- - Number of new adenoma detected at second right colon examination in both studies group(12 months)
- Number of overall serrated and/or adenomatous lesions in the whole colon(12 months)
- Characteristic of lesions detected (size, morphology)(12 months)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas