Combined Endoscopic and Laparoscopic Surgery (CELS) for Early Colon Cancer in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Resection margin
研究概览
简要总结
This is a pilot feasibility study on high risk patients due to frailty and comorbidity who have early stage colon cancer (UICC 1). We will use a novel resection technique with expected less risk of complications called the Combined Endoscopic and Laparoscopic Surgery (CELS). After the histopathologic evaluation. Patients will be placed in either low risk or high risk group. Depending on this, they will be followed for 3 years or referred to standard resection
详细描述
Combined Endoscopic and Laparoscopic Surgery (CELS) for early colon cancer in high risk patients
Investigator Morten Frederik Schlaikjær Hartwig
Local research group Ismael Gögenur Lasse Bremholm Hansen Mustafa Bulut Rasmus Dahlin Bojesen Jens Ravn Eriksen Susanne Eiholm Mads Klein Morten Rasmussen Bo Rud
International research group Phil Quirke Scarlet Brockmoeller
Background Colorectal cancer is the second most common cancer in Europe and the third most common cancer worldwide. The introduction of screening programs for colorectal cancer has resulted in an increased detection and incidence of early cancers (T1-T2). Early cancers are seen in 54% of the patients in the screening programs compared with 25 % of symptomatic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •UICC stage 1 colon cancer
- •ASA score min. 3 and/or WHO PS score min. 1
- •CELS eligible resection
- •Biopsy show adenocarcinoma or suspicious lesion
- •No preop chemo or radiotherapy
- •Accept inclusion
排除标准
- •Hereditary cancer
- •Rectal cancer
- •Radiation downstaging
结局指标
主要结局
Resection margin
时间窗: 1 month
R0, R1, R2
次要结局
- Complication rate(1 month)