Assessment of Cognitive and Functional Impairment in Older Patients After ERCP

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment
• Intervention / Treatment: Other: Neurocognitive function assessment

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults aged 60 years or older scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical Center (VUMC).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Research Subjects; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Patrick Yachimski, MD, MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 181485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No