Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction: a Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Duration of stent patency between stent insertion and recurrence of obstructive symptoms
研究概览
简要总结
Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal malignancies, but emergent surgical decompression is associated with high morbidity and mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an alternative to surgery and effectively decompress the colonic obstruction and allow for bowel preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents and covered stents. Covered stents have the advantage of less frequent stent occlusion by tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered stents are associated with less stent migration, although they appear to be more prone to tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered combination covered stent was developed. In the present study, the investigators evaluated the efficacy and safety of the newly designed covered stent by comparing it with the uncovered stent in patients with malignant colorectal obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20~85-year-old patients with malignant colorectal obstruction either by primary CRC or extracolonic malignancy
- •Patients with clinical obstructive symptoms confirmed by CT or colonoscopy
排除标准
- •Patients with evidence of bowel perforation or peritonitis
- •Cause of obstruction other than malignancy (bowel adhesion or benign stricture)
- •Multiple stricture
- •Lower rectal cancer obstruction (AV <5cm)
结局指标
主要结局
Duration of stent patency between stent insertion and recurrence of obstructive symptoms
时间窗: 2 years after the procedure
Time between stent insertion and recurrence of obstructive symptoms caused by tumor ingrowth, tumor overgrowth, or stent migration after stent placement
次要结局
- Number of patients with clinical success(2 years after the procedure)
- Number of patients with complications(2 years after the procedure)
- Number of patients with technical success(2 years after the procedure)
