Assessment of Cognitive and Functional Impairment in Older Patients After ERCP
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 2/17/2019 |
| Start Date: | February 8, 2019 |
| End Date: | June 2021 |
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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