Assessment of Cognitive and Functional Impairment in Older Patients After ERCP

Study Overview
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Brief Summary
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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.

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

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Other: Neurocognitive function assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 60 years or older Scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical Center (VUMC) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Research Subjects<br>All adults aged 60 years or older scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical Center (VUMC) will be invited to participate in the study. Invited patients who consent to participate as study subjects will undergo neurocognitive and functional assessment pre-procedure and at 90 days post-procedure. | Other: Neurocognitive function assessment<br>* Neurocognitive function will be assessed via a phone battery derived from standard cognitive tests proven feasible and valid to assess memory, attention, reasoning, and executive functioning. Functional status will also be assessed via phone. The duration of time required for the patient to complete telephone interview for neurocognitive and functional assessment will be approximately 45 minutes per time point.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cognitive impairment and/or functional disability | Number of subjects with an increase in impairment and/or disability after undergoing outpatient endoscopic retrograde cholangiopancreatography (ECRP) and/or endoscopic ultrasound (EUS) | 90 days |