Expired Study
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Nashville, Tennessee 37212


Purpose:

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.


Criteria:

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


NCT ID:

NCT03762954


Primary Contact:

Principal Investigator
Patrick Yachimski, MD, MPH
Vanderbilt University Medical Center

Amy Motley
Phone: 6153226281
Email: amy.motley@vumc.org


Backup Contact:

Email: tina.higginbotham@vumc.org
Tina Higginbotham
Phone: 6153224643


Location Contact:

Nashville, Tennessee 37212
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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