Assessment of Cognitive and Functional Impairment in Older Patients After ERCP

NCT03762954 | Completed

• 1 other identifier: 181485
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Neurocognitive function assessment OTHER

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.

Research Subjects

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Patrick Yachimski, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 4, 2018
• Study Start: February 8, 2019
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)