<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762954</url>
  </required_header>
  <id_info>
    <org_study_id>181485</org_study_id>
    <nct_id>NCT03762954</nct_id>
  </id_info>
  <brief_title>Assessment of Cognitive and Functional Impairment in Older Patients After ERCP</brief_title>
  <official_title>Assessment of Cognitive and Functional Impairment of Older Patients After Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic retrograde cholangiopancreatography (ERCP) is an interventional endoscopy&#xD;
      procedure utilized in the therapeutic management of pancreatobiliary diseases including&#xD;
      gallstones, bile duct strictures, leaks and infections, pancreatitis, and cancers of the bile&#xD;
      duct or pancreas. ERCP is classified as a high risk procedure. Potential adverse events&#xD;
      directly attributable to the technical aspects of ERCP include pancreatitis, hemorrhage,&#xD;
      infection, and bowel wall perforation. Other potential adverse events of ERCP may be less&#xD;
      apparent and/or unknown, such as risk of neurocognitive dysfunction. Overall, neurocognitive&#xD;
      dysfunction after medical procedures impacts quality of life, functional disability,&#xD;
      depression, and caregiver and societal burden.&#xD;
&#xD;
      The prevalence of postoperative neurocognitive dysfunction and disability following&#xD;
      interventional endoscopy procedures such as ERCP has not been reported. This prospective&#xD;
      observational study is designed to assess the prevalence of cognitive impairment and&#xD;
      functional disability after ERCP and endoscopic ultrasound (EUS) procedures in older&#xD;
      patients, and to assess whether specific patient and/or procedural factors are associated&#xD;
      with increased risk of adverse outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of cognitive impairment and/or functional disability</measure>
    <time_frame>90 days</time_frame>
    <description>Number of subjects with an increase in impairment and/or disability after undergoing outpatient endoscopic retrograde cholangiopancreatography (ECRP) and/or endoscopic ultrasound (EUS)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Research Subjects</arm_group_label>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurocognitive function assessment</intervention_name>
    <description>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.</description>
    <arm_group_label>Research Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adults aged 60 years or older scheduled to undergo outpatient ERCP and/or EUS at&#xD;
        Vanderbilt University Medical Center (VUMC).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 60 years or older&#xD;
&#xD;
          -  Scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical&#xD;
             Center (VUMC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;60 years&#xD;
&#xD;
          -  Inpatient status at the time of ERCP/EUS&#xD;
&#xD;
          -  Documented history of dementia&#xD;
&#xD;
          -  Inability to provide informed consent for study participation, implying baseline&#xD;
             neurocognitive dysfunction&#xD;
&#xD;
          -  Blind, deaf, or unable to speak English, as these conditions would preclude our&#xD;
             ability to perform assessments.&#xD;
&#xD;
          -  No access to a telephone to permit pre-procedure and 3 month post-procedure&#xD;
             neurocognitive assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Yachimski, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Patrick Yachimski</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762954
org study id: 181485
nct id: NCT03762954
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Prevalence of cognitive impairment and/or functional disability
time frame: 90 days
description: Number of subjects with an increase in impairment and/or disability after undergoing outpatient endoscopic retrograde cholangiopancreatography (ECRP) and/or endoscopic ultrasound (EUS)
arm group label: 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.
intervention type: Other
intervention name: Neurocognitive function assessment
description: 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.
arm group label: Research Subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Yachimski, MD, MPH
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Patrick Yachimski
investigator title: Principal Investigator
mesh term: Cognitive Dysfunction
sharing ipd: No