A Prospective Randomized Controlled Trial of Cold Snare Polypectomy vs. Conventional Polypectomy for Non-pedunculated Colorectal Adenomas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- R0 resection rate
研究概览
简要总结
A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.
详细描述
Diagnostic colonoscopy will be performed in all patients. If a polyp, appropriate for inclusion criteria, is identified, an endoscopic polypectomy will be assigned. All eligible polyps will be randomly assigned (1:1) to endoscopic polypectomy with either the cold snare resection or hot snare resection (control group). Randomization will be stratified using random numbers. After resection, the marginal mucosa will be carefully observed with used of magnification and image enhancement (near focus imaging or narrow band imaging) for determine residual tissue. The time period when the snare will be entered in the bowel lumen and until a polyp will be retrieved will be recorded by a stopwatch.
All polyps will be retrieved for morphological examination to estimate R0/R1resetion. After polypectomy all patients will be observed for 3-4 days in-hospital to diagnose and eliminate complications (delayed bleeding and perforations). All patients will have a control colonoscopy 6 months after polypectomy to investigate long-term results.
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
- Single (Participant)
盲法说明
Single-blinded
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-pedunculated colorectal adenomas who had provided written informed consent
排除标准
- •known coagulopathy.
- •polyposis of the alimentary tract.
- •inflammatory bowel disease.
- •malignant polyps.
- •associated diseases in the stage of decompensation
研究组 & 干预措施
Cold snare polypectomy
After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital
干预措施: Cold snare polypectomy (Procedure)
Hot snare polypectomy
After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital
干预措施: Hot snare polypectomy (Procedure)
结局指标
主要结局
R0 resection rate
时间窗: 14 days
Complete resection rate
时间窗: 1 day
次要结局
- Complication rate(14 days)
- Use of submucosal injection(1 day)
- The procedure time(1 day)
- The immediate bleeding or immediate perforation rate after polypectomy(1 day)
- Incidence of local recurrence(6 months)
- Polyp retrieval rate(1 day)