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临床试验/NCT03801070
NCT03801070已完成不适用

Radiological Predictors of Failure of Endoscopic Therapy or Need For Multiple Endoscopic Procedures in Patients With Walled Off Pancreatic Necrosis

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Identify WON imaging characteristics on cat-scan

研究概览

简要总结

This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis related admissions and readmission following endoscopic drainage, surgical or percutaneous procedures performed for the management of walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including hospital readmissions, WON resolution, procedure complications, WON related death) 3) endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic procedures performed for management of walled off necrosis (including additional EGD's, endoscopic drainage procedures, and/or necrosectomy)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Patients over 18 years of age who underwent endoscopic drainage of walled off pancreatic necrosis
  • Patients who did not require further intervention (either surgical, percutaneous, or endoscopic) following endoscopic drainage
  • Patients who required further intervention for walled off pancreatic necrosis (either surgical, percutaneous, or endoscopic) following endoscopic drainage.
  • Patients who underwent percutaneous or surgical interventions prior to endoscopic drainage

排除标准

  • Pancreatic pseudocysts without any solid debris
  • Under 18 years of age at the time of endoscopic drainage

结局指标

主要结局

Identify WON imaging characteristics on cat-scan

时间窗: through study completion, an average of 260 days

Characteristics on cat-scan that are predictive of requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis

Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications)

时间窗: through study completion, an average of 260 days

Imaging classification method to efficiently report these imaging characteristics

Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death)

时间窗: through study completion, an average of 260 days

Characteristics to develop a predictive model that will help to identify patients at high risk for requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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