NCT05825664招募中不适用
Comparison of the Efficiency and Safety of Underwater Endoscopic Mucosal Resection and Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps
University of Medicine and Pharmacy at Ho Chi Minh City2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2023年4月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- en bloc resection
研究概览
简要总结
A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps
详细描述
- Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center.
- Randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Conventional endoscopic mucosal resection (CEMR).
- The time of local recurrence assessment depends on the histopathology of polyps. Polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months.
- Collecting variables which consist of primary and secodary outcomes.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age > 18 years
- •Non-pedunculated polyps of 10 mm or more in size
- •Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification
- •Patients must sign an informed consent form prior to registration in study
排除标准
- •Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign)
- •Type 3 according to NICE classification
- •Colorectal cancer
- •Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease)
- •Hemostasis disorder (INR > 1.5; platelets < 100000/mm3)
结局指标
主要结局
en bloc resection
时间窗: immediately after the procedure
Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more
Curative rate
时间窗: through study completion, an average of 6 months
Curative rate for non-pedunculated colorectal polyps of 10 mm or more
次要结局
- Complication rate(up to 2 weeks)
- Procedure time(during the procedure)
- Local recurrence rate(6 months)
研究者
Le Dinh Quang
Principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
研究点 (2)
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