Assessment of Cognitive and Functional Impairment of Older Patients After Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound
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
- 否
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
Patrick Yachimski
Principal Investigator
Vanderbilt University Medical Center
