Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.
详细描述
Rationale:
Lowering the EMR recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks.
Objective:
To investigate whether thermal ablation EMR with snare tip soft coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.
Study design:
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.
排除标准
- •Previously attempted intervention
- •Polyps with any signs of invasive malignancy
- •Presence or suspicion of inflammatory bowel disease
- •En bloc resection
- •Incomplete resection
研究组 & 干预措施
EMR plus snare tip soft coagulation
Post procedural prophylactic coagulation of the entire margin of the resection site creating a 2-3mm rim.
干预措施: Snare tip soft coagulation (Procedure)
Standard EMR
No prophylactic coagulation
结局指标
主要结局
Recurrence
时间窗: 6 months
Adenoma recurrence at resection site
次要结局
未报告次要终点