Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
Comparison of Coventional Endoscopic Submucosal Dissection and Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm
This study is aimed to analyze the outcomes after conventional endoscopic submucosal dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk.
Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in diameter with snaring, then resected by using an electric current.
The investigators expect optimized ESD with snaring can provide more time-saving procedure with comparable en-bloc resection rate and perforation rate, when compared with the conventional ESD method.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Seoul、大韩民国
- 招聘中
- Asan Medical Center, University of Ulsan College of Medicine
-
接触：
- Jeong-Sik Byeon, MD
- 电话号码：+82-2-3010-3905
- 邮箱：jsbyeon@amc.seoul.kr
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- colorectal laterally spreading tumor that is more than 20 mm in diameter
- other elevated or flat colorectal neoplasm without stalk, that is more than 20 mm in diameter
Exclusion Criteria:
- colorectal neoplasms that are proven or suspected to be invaded more than submucosal invasion
- colorectal neoplasms that have severe fibrosis beneath the target lesion
- patient's refusal to participate this study
- less than 18 years old
- subjects who cannot consent voluntarily due to the communication difficulty
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：conventional ESD
Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm.
|
|
|
实验性的：Optimized ESD with snaring
Optimized ESD with snaring arm indicates the group in which optimized ESD with snaring method is applied for the dissection of colorectal neoplasm.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
procedure time
大体时间：8 months
|
8 months
|
|
En Bloc resection rate
大体时间：8 months
|
8 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
histologic complete resection rate
大体时间：8 months
|
8 months
|
|
|
complication rate
大体时间：8 months
|
perforation rate, bleeding rate
|
8 months
|
合作者和调查者
调查人员
- 首席研究员：Jeong-Sik Byoen, MD、Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Conventional ESD的临床试验
-
Shanghai Zhongshan HospitalEvangelisches Krankenhaus Düsseldorf完全的
-
Asian Institute of Gastroenterology, IndiaNanyang Technological University完全的
-
Carol Davila University of Medicine and Pharmacy招聘中