Assessment of Cognitive and Functional Impairment in Older Patients After ERCP

Vanderbilt University Medical Center

Status: Completed

Conditions: Cognitive Impairment

Treatments: Other: Neurocognitive function assessment

Study type: Observational

Funder types: Other

Identifiers

NCT03762954

181485

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

215 participants in 1 patient group

Research Subjects

Description:

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.

Treatment:

Other: Neurocognitive function assessment