Assessment of Cognitive and Functional Impairment in Older Patients After ERCP

Completed

• Conditions: Cognitive Impairment
• Interventions: Other: Neurocognitive function assessment

• Registration Number: NCT03762954
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-04
• Study Start: 2019-02-08
• Primary Completion: 2024-04-04
• Study Completion: 2024-04-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Research Subjects	Neurocognitive function assessment	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of cognitive impairment and/or functional disability	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)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States