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临床试验/NCT01750619
NCT01750619招募中不适用

Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions

California Pacific Medical Center Research Institute1 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
8,000
试验地点
1
主要终点
Technical success.

研究概览

简要总结

To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age >18 years that have been referred for endoscopic treatment of GI lesions.

排除标准

  • Patients for whom endoscopic treatment was not performed.

结局指标

主要结局

Technical success.

时间窗: 1 day to 3 months

Technical success is defined as complete resection confirmed by the endoscopic absence of adenomatous tissue after inspection with high-definition white light and narrow-band imaging.

次要结局

  • Short term recurrence rate(Less than 1 year)
  • Long term recurrence rate(Greater than 1 year)
  • Adverse event rate(up to 1 month post procedure.)
  • Endoscopic en bloc resection rate(Immediate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Binmoeller

Interventional Endoscopy Services Program Director

California Pacific Medical Center Research Institute

研究点 (1)

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