Assessment of Cognitive and Functional Impairment in Older Patients After ERCP

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03762954
• Other study ID #: 181485
• Status: Enrolling by invitation
• Start date: February 8, 2019
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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