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临床试验/NCT02640781
NCT02640781Unknown不适用

Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction: a Prospective, Multicenter Study

Yonsei University2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2015年12月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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