<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/NCT03771547</url>
  </required_header>
  <id_info>
    <org_study_id>DC-0918</org_study_id>
    <nct_id>NCT03771547</nct_id>
  </id_info>
  <brief_title>ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events</brief_title>
  <official_title>ERCP in Super-aged Patients Considering Difficult Cannulation: Challenges and Adverse Events</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Today 11 percent of China's population is over the age of 65, and according to United&#xD;
      Nations, it will take China just 20 years for the proportion of the elderly population to&#xD;
      double to 25%. As life expectancy has increased, application of Endoscopic Retrograde&#xD;
      Cholangiopancreatography (ERCP) in super-aged (≥80 years of age) is no longer limited with&#xD;
      increasing prevalence of choledocholithiasis, and malignancy in advancing age. This&#xD;
      increasing may come with more difficulty in cannulation or more complications in senior&#xD;
      patients. Regarding difficult cannulation, little is known about grading difficulty in the&#xD;
      elderly and its relation with adverse events. Therefore, it is time to evaluate the risk&#xD;
      factors of adverse events in super-aged patients with difficult bile duct cannulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AIM: To evaluate the incidence, causes, and management of difficult biliary cannulation&#xD;
      during ERCP in elderly patients and its role as a risk factor for adverse events.&#xD;
&#xD;
      METHODS: A total of 614 patients, with a mean age of 65.3±16.7 years, underwent ERCP during&#xD;
      the study period, were prospectively managed and divided into two groups based on their age.&#xD;
      There were 146 patients aged 80 years or older in group A with the mean age of 84±3.4 years.&#xD;
      The primary outcome measurements were the difficulty grade of papilla cannulation, clinical&#xD;
      outcomes, and ERCP-related complications in the two groups. The adverse events were analyzed&#xD;
      by logistic regression about patient age, co-morbidities, indications, and difficult&#xD;
      cannulation grading.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Adverse events in difficult cannulation patients</measure>
    <time_frame>30 days</time_frame>
    <description>Multi-variate regression will be used to check the risk factors of adverse events</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">614</enrollment>
  <condition>Post-ERCP Acute Pancreatitis</condition>
  <condition>Cholangitis</condition>
  <arm_group>
    <arm_group_label>More 80</arm_group_label>
    <description>The first group included ERCP patients aged 80 and above.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Less 80</arm_group_label>
    <description>The second group included those ERCP patients younger than 80.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ERCP</intervention_name>
    <arm_group_label>Less 80</arm_group_label>
    <arm_group_label>More 80</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        No specific restrictions on selecting the patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent ERCP between July 2016 and January 2018.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded the patients who underwent ERCP for the objectives of follow up, stent&#xD;
             removing or taking a biopsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>94 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Lin Miao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 8, 2018</last_update_submitted>
  <last_update_submitted_qc>December 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ERCP</keyword>
  <keyword>Elderly</keyword>
  <keyword>Difficult cannulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Cholangitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03771547
org study id: DC-0918
nct id: NCT03771547
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Today 11 percent of China's population is over the age of 65, and according to United
      Nations, it will take China just 20 years for the proportion of the elderly population to
      double to 25%. As life expectancy has increased, application of Endoscopic Retrograde
      Cholangiopancreatography (ERCP) in super-aged (≥80 years of age) is no longer limited with
      increasing prevalence of choledocholithiasis, and malignancy in advancing age. This
      increasing may come with more difficulty in cannulation or more complications in senior
      patients. Regarding difficult cannulation, little is known about grading difficulty in the
      elderly and its relation with adverse events. Therefore, it is time to evaluate the risk
      factors of adverse events in super-aged patients with difficult bile duct cannulation.
AIM: To evaluate the incidence, causes, and management of difficult biliary cannulation
      during ERCP in elderly patients and its role as a risk factor for adverse events.

      METHODS: A total of 614 patients, with a mean age of 65.3±16.7 years, underwent ERCP during
      the study period, were prospectively managed and divided into two groups based on their age.
      There were 146 patients aged 80 years or older in group A with the mean age of 84±3.4 years.
      The primary outcome measurements were the difficulty grade of papilla cannulation, clinical
      outcomes, and ERCP-related complications in the two groups. The adverse events were analyzed
      by logistic regression about patient age, co-morbidities, indications, and difficult
      cannulation grading.
observational model: Case-Control
time perspective: Prospective
measure: Adverse events in difficult cannulation patients
time frame: 30 days
description: Multi-variate regression will be used to check the risk factors of adverse events
arm group label: More 80
description: The first group included ERCP patients aged 80 and above.
arm group label: Less 80
description: The second group included those ERCP patients younger than 80.
intervention type: Diagnostic Test
intervention name: ERCP
arm group label: Less 80
arm group label: More 80
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 94 Years
last name: Lin Miao, PhD
role: Principal Investigator
affiliation: Nanjing Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Cholangitis
sharing ipd: Undecided