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临床试验/NCT03762954
NCT03762954已完成不适用

Assessment of Cognitive and Functional Impairment of Older Patients After Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2019年2月8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
215
试验地点
1
主要终点
Prevalence of cognitive impairment and/or functional disability

研究概览

简要总结

Endoscopic retrograde cholangiopancreatography (ERCP) is an interventional endoscopy procedure utilized in the therapeutic management of pancreatobiliary diseases including gallstones, bile duct strictures, leaks and infections, pancreatitis, and cancers of the bile duct or pancreas. ERCP is classified as a high risk procedure. Potential adverse events directly attributable to the technical aspects of ERCP include pancreatitis, hemorrhage, infection, and bowel wall perforation. Other potential adverse events of ERCP may be less apparent and/or unknown, such as risk of neurocognitive dysfunction. Overall, neurocognitive dysfunction after medical procedures impacts quality of life, functional disability, depression, and caregiver and societal burden.

The prevalence of postoperative neurocognitive dysfunction and disability following interventional endoscopy procedures such as ERCP has not been reported. This prospective observational study is designed to assess the prevalence of cognitive impairment and functional disability after ERCP and endoscopic ultrasound (EUS) procedures in older patients, and to assess whether specific patient and/or procedural factors are associated with increased risk of adverse outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Adults aged 60 years or older
  • Scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical Center (VUMC)

排除标准

  • Age <60 years
  • Inpatient status at the time of ERCP/EUS
  • Documented history of dementia
  • Inability to provide informed consent for study participation, implying baseline neurocognitive dysfunction
  • Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform assessments.
  • No access to a telephone to permit pre-procedure and 3 month post-procedure neurocognitive assessment

结局指标

主要结局

Prevalence of cognitive impairment and/or functional disability

时间窗: 90 days

Number of subjects with an increase in impairment and/or disability after undergoing outpatient endoscopic retrograde cholangiopancreatography (ECRP) and/or endoscopic ultrasound (EUS)

次要结局

未报告次要终点

研究者

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

Patrick Yachimski

Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

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