NCT04647266已完成不适用
Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2016年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
研究概览
简要总结
The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.
Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.
There is currently no score established for the colo-rectal endoscopic submucosal dissection.
- To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
- Allow to obtain an estimation of number of patients required for a larger study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:
- •Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma
- •Mucosal tumors with submucosal fibrosis
- •Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis
- •Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus
- •Male or female patients aged ≥ 18 years old
- •Patients able to fill in questionnaires written in French
排除标准
- •Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
结局指标
主要结局
To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
时间窗: From 2016 to 2020
次要结局
- Allow to obtain an estimation of number of patients required for a larger study(From 2016 to 2020)
研究者
研究点 (1)
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