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NCT03762954 · ClinicalTrials.gov registry record
Assessment of Cognitive and Functional Impairment in Older Patients After ERCP
A clinical trial of Cognitive Impairment, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 215
- Enrollment target
- 1
- Study location
NCT03762954: Completed study of Cognitive Impairment, sponsored by Vanderbilt University Medical Center.
NCT03762954 is a study of Cognitive Impairment that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 215 participants, below the 664-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03762954, a study of Cognitive Impairment, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 215 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of subjects with an increase in impairment and/or disability after undergoing outpatient endoscopic retrograde cholangiopancreatography (ECRP) and/or endoscopic ultrasound (EUS)
Conditions Studied
Interventions
- OTHER Neurocognitive function assessment
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2019-02-08 |
| Est. Completion | 2024-04-04 |
What the finished NCT03762954 record still lists
NCT03762954 is an observational study that tracks outcomes without assigning an intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 664-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Cognitive Impairment appearing as the primary indexed condition, and to 1 intervention - of which Neurocognitive function assessment is the first listed.
NCT03762954 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT03762954 about?
NCT03762954 is a clinical study titled "Assessment of Cognitive and Functional Impairment in Older Patients After ERCP". 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 classif...
What is the current status of trial NCT03762954?
This trial is currently completed. The enrollment target is 215 participants. The study started on 2019-02-08. Estimated completion is 2024-04-04.
What conditions does trial NCT03762954 study?
This clinical trial studies the following conditions: Cognitive Impairment.
What interventions are being tested in trial NCT03762954?
The interventions under investigation include: Neurocognitive function assessment (OTHER).
Who is sponsoring clinical trial NCT03762954?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03762954 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03762954's enrollment target sits among peer trials
215 27th of 105 higher than 79 of 105 other Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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