Colorectal Adenoma Detection Using Spectral Focused Imaging Versus White Light Imaging: a Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 698
- 试验地点
- 8
- 主要终点
- Adenoma detection rate (ADR)
研究概览
简要总结
Spectral Focused Imaging (SFI) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal energy is further concentrated on the absorption peak wavelength of microvessels by using digital spectral processing techniques. This technology, combined in the latest generation SonoScape's endoscopes (SonoScape Co, Shenzhen, China) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with SFI are encouraging but are scanty and limited to back-to back studies.
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether SFI is superior to WLI endoscopy in terms of adenoma detection
详细描述
45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to SFI (SFI group) or WLI (WLI group) during insertion and withdrawal phase of colonoscopy. All procedures are performed with a high-definition HD-580 series videocolonscopes with or without magnification (SonoScape Co, Shenzhen, China).
The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 45 to 85
- •Patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (FIT) results, or experiencing gastrointestinal symptoms
- •Capable of providing informed consent and agreeing to participate
- •Able and willing to follow all research processes
排除标准
- •Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
- •Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
- •Pregnant or lactating patients;
- •Known to have polyposis syndrome;
- •Patients with gastrointestinal bleeding;
- •Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
- •Patients with contraindications to tissue biopsy;
- •History of allergies to the ingredients in intestinal cleansers;
- •Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.
- •Researchers believe that patients are not suitable to participate in the trial;
- •Have had drug or alcohol abuse or psychological disorders in the past five years.
研究组 & 干预措施
SFI
Spectral Focused Imaging
干预措施: Spectral Focused Imaging (Device)
WLI
White Light Imaging
干预措施: White Light Imaging (Device)
结局指标
主要结局
Adenoma detection rate (ADR)
时间窗: 14 days
ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy
次要结局
- Polyp Detection Rate(PDR)(14 days)
- Sessile serrated lesion detection rate (SSLDR)(14 days)
- Advanced Adenoma Detection Rate(14 days)
- Mean number of polyps per patient(14 days)
- Mean number of Adenomas per patient(MAP)(14 days)
- Detection Rate of Polyps of Different Sizes(14 days)
- Detection Rate of Adenomas with Different Morphologies(14 days)
- Average Number of Adenomas with Different Morphologies(14 days)
- Average Number of Polyps of Different Sizes(14 days)
- Detection Rate of Adenomas of Different Sizes(14 days)
- Average Number of Adenomas of Different Sizes(14 days)
- Detection Rate of Adenomas in Different Locations(14 days)
- Average Number of Adenomas in Different Locations(14 days)
- Detection Rate of Polyps in Different Locations(14 days)
- Average Number of Polyps in Different Locations(14 days)
- Detection Rate of Polyps with Different Morphologies(14 days)
- Average Number of Polyps with Different Morphologies(14 days)
- Insertion Time of Colonoscopy(14 days)
- Withdrawal Time of Colonoscopy(14 days)
- Cecal Intubation Rate(14 days)
研究者
Xiaobo Li
Chief physician
RenJi Hospital