Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Recurrence-Free Survival
研究概览
简要总结
This multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection.
Patients with non-curative resection following endoscopic treatment will be enrolled across multiple centers and managed according to real-world clinical decisions, including additional surgery or surveillance. Baseline demographic, endoscopic, and pathological characteristics will be systematically collected.
The primary objective is to compare recurrence and survival outcomes between different management strategies. Secondary objectives include identifying prognostic factors associated with recurrence and developing a risk stratification model to guide individualized treatment decisions.
All participants will undergo standardized follow-up according to clinical guidelines. This study is expected to provide real-world evidence to refine risk assessment, reduce unnecessary surgery, and improve personalized management for patients with early colorectal cancer after non-curative endoscopic resection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Patients with early colorectal cancer confirmed by histopathology;
- •Patients who underwent endoscopic resection (including EMR, ESD, or equivalent techniques);
- •Pathological diagnosis indicating non-curative resection, defined by the presence of at least one of the following: positive resection margin, submucosal invasion depth >1000 μm, poor differentiation, lymphovascular invasion, perineural invasion, or high-grade tumor budding;
- •Availability of complete clinicopathological and follow-up data;
- •Patients managed with either additional surgery or surveillance after endoscopic resection.
排除标准
- •Patients with synchronous advanced colorectal cancer or distant metastasis at baseline;
- •History of other active malignancies;
- •Patients with inflammatory bowel disease, familial adenomatous polyposis, or other hereditary colorectal cancer syndromes;
- •Patients who received neoadjuvant therapy before endoscopic resection;
- •Incomplete pathological data or missing key variables;
- •Loss to follow-up or follow-up duration less than 6 months.
研究组 & 干预措施
Surveillance
Patients managed with surveillance after non-curative endoscopic resection, including regular endoscopic and imaging follow-up without additional surgical intervention.
干预措施: Surveillance (Other)
Additional Surgery
Patients who underwent additional surgical resection following non-curative endoscopic resection based on pathological risk factors and clinical decision-making.
干预措施: Additional Surgery (Procedure)
结局指标
主要结局
Recurrence-Free Survival
时间窗: Up to 2 years
次要结局
- Association Between High-Risk Pathological Factors and Recurrence(Up to 2 years)