Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 845
- 试验地点
- 7
- 主要终点
- Adenoma detection rate (ADR)
研究概览
简要总结
- Study on Adenoma Detection Rate (ADR) Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI);
- Study Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI) for Detection Rates of Sessile Serrated Lesions (SSLs), Total Polyp Detection Rate, and Advanced Adenoma Detection Rate;
- Study on Polyp Characteristics (Size, Location, etc.) Observed Using Conventional White Light Endoscopy (WLI) and Enhanced White Light Endoscopy (E-WLI).
详细描述
Before colonoscopy, gastroenterology specialists stratified eligible patients according to 1) colorectal cancer screening, 2) positive fecal immunochemical test (FIT) results or gastrointestinal symptoms, and 3) follow-up colonoscopy after colorectal polyp treatment. Patients were then randomized in a 1:1 ratio to receive either colonoscopy with enhanced white light imaging (E-WLI group) or high-definition conventional white light imaging (WLI group) during both insertion and withdrawal phases. Randomization was based on random number lists generated by the coordinating center for each participating site. Endoscopists performing the procedures were not involved in generating the randomization sequence. All procedures were performed by experienced endoscopists at participating centers (>2000 colonoscopy screenings). All procedures utilized endoscopes with "Xiaohua Tanying" technology that incorporated E-WLI functionality. Bowel preparation was assessed and graded by the performing endoscopist using the Boston Bowel Preparation Scale (BBPS). Endoscopy specialists and healthcare facility staff followed standard procedures for patient management and monitoring, including anesthesia. Cecal intubation was verified by the endoscopist through photographic documentation identifying the ileocecal valve and appendiceal orifice. Insertion and withdrawal times were measured through video recording analysis, excluding time spent on therapeutic interventions and washing. Endoscopists were required to maintain a minimum withdrawal inspection time of 6 minutes (with at least 2 minutes each for right colon, transverse colon, and left colon). Regardless of group assignment (E-WLI or WLI), when polyps were detected during the procedure, they were observed using both WLI and E-WLI (2 modes), with images captured in each mode. The location, size, and morphology (Paris classification) of all polyps were documented. All polyps were removed (or biopsied if unresectable), and pathological results were obtained. For hyperplastic polyps in the rectum, if more than 3 diminutive polyps were present, only the first 3 detected polyps required management.
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
- •1. Male or female aged 45 to 85
- •2. Patients undergoing colonoscopy for colorectal cancer screening, positive fecal immunochemical test (FIT) results, gastrointestinal symptoms, or follow-up examination after colorectal polyp treatment
- •3. Capable of providing informed consent and agreeing to participate
- •4. Able and willing to follow all research processes
排除标准
- •1. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
- •2. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
- •3. Have had drug or alcohol abuse or psychological disorders in the past five years.
- •4. Pregnant or lactating patients;
- •5. Known to have polyposis syndrome;
- •6. Patients with gastrointestinal bleeding;
- •7. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
- •8.Patients with contraindications to tissue biopsy;
- •9. History of allergies to the ingredients in intestinal cleansers;
- •10. 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.
- •11. Researchers believe that patients are not suitable to participate in the trial.
研究组 & 干预措施
E-WLI
Enhanced White Light Imaging
干预措施: Enhanced White Light Imaging (Device)
WLI
White Light lmaging
干预措施: White Light lmaging (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)
- 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)
- Polyp Detection Rate(PDR)(14 days)
- Sessile serrated lesion detection rate (SDR)(14 days)
- Advanced Adenoma Detection Rate (aADR)(14 days)
- Mean number of polyps per patient (MPP)(14 days)
- Mean number of Adenomas per patient(MAP)(14 days)
- Detection Rate of Polyps of Different Sizes(14 days)
- Detection Rate of Polyps in Different Locations(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)
- 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)
研究者
Xiaobo Li
Chief physician
RenJi Hospital
