French Colorectal ESD Cohort in Experts Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 25
- 主要终点
- R0 Resection rate of submucosal dissection for superficial colorectal lesions
研究概览
简要总结
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.
Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.
A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.
The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.
详细描述
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.
Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.
A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.
The aim of this French multicenter cohort is to analyze the results of colorectal submucosal dissection on a large scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •All patients addressed for a colorectal ESD
排除标准
- •Opposition notified in the context of a non-opposition form after reading the information notice
结局指标
主要结局
R0 Resection rate of submucosal dissection for superficial colorectal lesions
时间窗: Month 1
R0 Resection rate according to the definition of of the European Society of Gastrointestinal Endoscopy.
次要结局
- Effectiveness of histological prediction of superficial colorectal lesions treated according to the technological tools used.(Month 1)
- Endoscopic recurrence rate during the first endoscopic follow-up(Month 6)
- Monobloc resection rate(Day 1)
- Monobloc resection rate exclusively in ESD.(Day 1)
- Curative resection rate(Month 1)
- Optimal dissection rate(Month 1)
- 30-day complication rate(Month 1)
- Curative endoscopic resection rate without surgical management at 36 months(Month 36)
- Number of metachronous colorectal lesions at 36 months(Month 36)
- Surgery rate at 36 months(Month 36)
- Recurrence rate at 36 months(Month 36)
- Impact of center volume on oncological outcomes, technical outcomes, and procedural complications.(Month 1)
- Compare oncological and technical outcomes and procedural complications based on colonic or rectal location.(Month 1)
- Compare procedural outcomes based on the different traction strategies used(Month 1)
- Analyze the learning curve of new trainees at the time of implementation of the submucosal dissection curriculum of the French Society of Digestive Endoscopy.(statitistic analysis)
- Creation of a difficulty score predicting the success of ESD (R0 resection without perforation)(Month 1)