Impact of Acetic Acid-Indigo Carmine Chromocolonoscopy on Proximal Sessile Serrated Lesions: a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,689
- 试验地点
- 1
研究概览
简要总结
Chromocolonoscopy with acetic acid and indigo carmine has shown promise for improving the detection of sessile serrated lesions (SSLs), the precursor lesions responsible for a substantial proportion of interval colorectal cancers. Previous studies have demonstrated its potential to enhance visualization of both adenomatous and non-adenomatous polyps, particularly the subtle SSLs that are frequently missed during conventional white-light colonoscopy. However, high-quality randomized controlled trials comparing chromocolonoscopy with standard white-light imaging to provide definitive evidence on its efficacy for SSL detection are lacking. We therefore conducted a multicenter, prospective, randomized controlled trial to evaluate the diagnostic yield of acetic acid-indigo carmine chromocolonoscopy versus standard colonoscopy for SSL detection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients whose age are between 45-85
- •Patients who have indications for screening
- •Patients who have signed inform consent form.
排除标准
- •Patients undergoing surveillance colonoscopy after polypectomy or therapeutic colonoscopy for known polyps
- •Patients with a history of colonoscopy within the past 5 years
- •Patients with highly suspected or confirmed colorectal cancer
- •Patients with alarming signs or symptoms: hematochezia, melena, unexplained anemia, weight loss, abdominal mass, positive digital rectal examination
- •Pregnant or breastfeeding women
- •Patients with gastrointestinal obstruction
- •Patients with inflammatory bowel disease, colonic polyposis, or melanosis coli
- •Patients with coagulation disorders or who have taken antiplatelets or anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy
- •Patients currently participating in another clinical trial or who have participated in another clinical trial within the preceding 60 days
- •Patients with failed cecal intubation for any reason (e.g., obstructing lesion, intolerance of the procedure)
- •Patients with an Aronchick bowel preparation score >3 at colonoscope insertion, indicating inadequate preparation requiring a repeat bowel preparation
- •Patients who have used bowel preparation agents not recommended by guidelines, such as oral sodium phosphate or senna
- •Patients with known allergy to acetic acid-indigo carmine, brilliant blue dye, or medications related to colonoscopy
- •Patients with missing essential information in the case report form prior to enrollment
研究者
Zhaoshen Li
M.D., Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Changhai Hospital