A Prospective, Randomized, Non-inferiority Study to Compare Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection and Hot Snare Endoscopic Mucosal Resection in Treatment for 10-19 mm Non-pedunculated Colorectal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 18
- 主要终点
- Complete resection rate
研究概览
简要总结
This is a prospective, randomized, open-label, non-inferiority, multiple-center trial. Outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (CS-EMR) or hot snare endoscopic mucosal resection (HS-EMR). This study aims to compare the efficacy and safety of CS-EMR or HS-EMR for the resection of non-pedunculated colorectal polyps sized 10-19mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age;
- •undergo colonoscopy in the Digestive Endoscopy Center of Peking Union Medical College Hospital, Beijing Tsinghua Changgung Hospital or Seventh Medical Center, General Hospital of the Chinese People's Liberation Army;
- •volunteer to participate in this study and sign informed consent;
- •at least one polyp sized 10-19 mm (Paris classification Is or IIa) by colonoscopy.
排除标准
- •American Society of Anesthesiologists (ASA) status class 3 or above;
- •poor bowel preparation (Boston bowel preparation scale < 6 points);
- •known or endoscopic features indicating the submucous infiltration or malignancy;
- •oral anti-coagulants, or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency (platelets<50000 cells/mm3 or INR>1.5);
- •a history of colorectal resection;
- •emergency colonoscopy (hemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients);
- •inflammatory bowel disease, familial polyposis, and colorectal cancer;
- •pregnancy or lactation;
- •severe cardiopulmonary dysfunction, liver cirrhosis, chronic kidney disease, other malignant tumors, or severe infectious diseases.
研究组 & 干预措施
Cold snare endoscopic mucosal resection (CS-EMR)
Eligible colorectal polyps sized 10-19mm will be resected by CS-EMR
干预措施: Cold snare endoscopic mucosal resection (Procedure)
Hot snare endoscopic mucosal resection (HS-EMR)
Eligible colorectal polyps sized 10-19mm will be resected by HS-EMR
干预措施: Hot snare endoscopic mucosal resection (Procedure)
结局指标
主要结局
Complete resection rate
时间窗: Within 14 days
The resection is considered histologically complete if the lateral margins of the resected polyps are surrounded by normal tissue and the vertical margin is free of neoplasia tissue. If en-bloc resection is not achieved, 5 biopsies (4 biopsies obtained in a 4-quadrant fashion from the polypectomy site margins; 1 biopsy from the base) are applied to evaluate histological completeness of resection.
次要结局
- En-bloc resection rate(Within 1 day)
- Intraprocedural bleeding(Within 1 day)
- Intraprocedural perforation(Within 1 day)
- Delayed bleeding(Within 14 days)
- Delayed perforation(Within 14 days)
- Number of clips used(Within 1 day)
- Total cost(Within 1 day)
- Resection time(Within 1 day)
研究者
Qingwei Jiang
attending physician
Peking Union Medical College Hospital