NCT06937671招募中不适用
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 4
- 主要终点
- Recurrence of polyps
研究概览
简要总结
The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps.
Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (age 18 years or older)
- •Polyp size of at least 20 mm
- •- Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)
排除标准
- •Polyps with previous failed resection attempts or polyp recurrence
- •Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)
- •Polyps with nodules too large (>1-1.5cm) for the use of a cold snare
- •Inflammatory bowel disease
研究组 & 干预措施
Cold EMR
Active Comparator
Control group patients that receive standard cold EMR treatment.
干预措施: Cold EMR (Procedure)
Hybrid cold EMR
Experimental
Intervention group patients. Patients will receive hybrid EMR treatment.
干预措施: Hybrid EMR (Procedure)
结局指标
主要结局
Recurrence of polyps
时间窗: 3-6 months after the procedure
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
次要结局
- Adverse events(3-6 months after the procedure)
- Polyp recurrence rates(3-6 months after EMR procedure)
- Cost benefit analysis(3-6 months after the procedure)
- Subgroup polyp recurrence rate(3-6 months after the procedure)
- Adverse events(3-6 months after the procedure)
- Polyp recurrence rates(3-6 months after EMR procedure)
- Cost benefit analysis(3-6 months after the procedure)
- Subgroup polyp recurrence rate(3-6 months after the procedure)
研究者
Shah,Tilak
Medical Doctor
The Cleveland Clinic
研究点 (4)
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