<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/NCT02983331</url>
  </required_header>
  <id_info>
    <org_study_id>GK11</org_study_id>
    <nct_id>NCT02983331</nct_id>
  </id_info>
  <brief_title>Mortality After Endoscopic Retrograde Cholangiopancreatography</brief_title>
  <official_title>Patients With Mortality After Endoscopic Retrograde Cholangiopancreatography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gulsah Karaoren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aimed to overview patients with specific and non-specific&#xD;
      complications who admitted to intensive care unit following endoscopic retrograde&#xD;
      cholangiopancreatography and had fatal course in the facility&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators retrospectively reviewed patients who underwent elective or emergent&#xD;
      endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal&#xD;
      anesthesia (lidocaine spray) with routine monitoring (including electrocardiography,&#xD;
      non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation&#xD;
      protocol (midazolam 0.02 mgkg-1; fentanyl, 1 mgkg-1; propofol 1 mgkg-1) between 2011 and 2016&#xD;
      after approval of local ethics committee of Umraniye Training Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With endoscopic retrograde cholangiopancreatography Related complications</measure>
    <time_frame>5 years</time_frame>
    <description>We retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of anaesthesia related mortality of the endoscopic retrograde cholangiopancreatographyprocedure under sedation</measure>
    <time_frame>5 years</time_frame>
    <description>We identified patients who developed complications during procedure and admitted to intensive care unit (ICU).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Value of Charlson comorbidity index (CCI) score for predicting mortality</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1471</enrollment>
  <condition>Cholangiopancreatography, Endoscopic Retrograde</condition>
  <condition>Mortality</condition>
  <condition>Deep Sedation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>complications during procedure</intervention_name>
    <description>patients may have anesthesia related complications during procedure</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We retrospectively reviewed 1471 patients who underwent elective or emergent ERCP at&#xD;
        semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring&#xD;
        (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen&#xD;
        saturation) and standard sedation protocol&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent elective or emergent ERCP at semi-prone position with routine&#xD;
             monitoring and standard sedation protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who discharged to ward after treatment and follow-up in ICU&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gulsah Karaoren, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umraniye Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Umraniye Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Katsinelos P, Lazaraki G, Chatzimavroudis G, Gkagkalis S, Vasiliadis I, Papaeuthimiou A, Terzoudis S, Pilpilidis I, Zavos C, Kountouras J. Risk factors for therapeutic ERCP-related complications: an analysis of 2,715 cases performed by a single endoscopist. Ann Gastroenterol. 2014;27(1):65-72.</citation>
    <PMID>24714755</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gulsah Karaoren</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.</ipd_description>
  </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/NCT02983331
org study id: GK11
nct id: NCT02983331
lead sponsor: 
has dmc: No
In this study, the investigators aimed to overview patients with specific and non-specific
      complications who admitted to intensive care unit following endoscopic retrograde
      cholangiopancreatography and had fatal course in the facility
The investigators retrospectively reviewed patients who underwent elective or emergent
      endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal
      anesthesia (lidocaine spray) with routine monitoring (including electrocardiography,
      non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation
      protocol (midazolam 0.02 mgkg-1; fentanyl, 1 mgkg-1; propofol 1 mgkg-1) between 2011 and 2016
      after approval of local ethics committee of Umraniye Training Hospital.
time perspective: Retrospective
measure: Number of Participants With endoscopic retrograde cholangiopancreatography Related complications
time frame: 5 years
description: We retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol
measure: Rate of anaesthesia related mortality of the endoscopic retrograde cholangiopancreatographyprocedure under sedation
time frame: 5 years
description: We identified patients who developed complications during procedure and admitted to intensive care unit (ICU).
measure: Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality
time frame: 5 years
measure: Value of Charlson comorbidity index (CCI) score for predicting mortality
time frame: 5 years
intervention type: Procedure
intervention name: complications during procedure
description: patients may have anesthesia related complications during procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 42 Years
maximum age: 90 Years
healthy volunteers: No
last name: Gulsah Karaoren, MD
role: Principal Investigator
affiliation: Umraniye Research Hospital
facility: 
country: Turkey
citation: Katsinelos P, Lazaraki G, Chatzimavroudis G, Gkagkalis S, Vasiliadis I, Papaeuthimiou A, Terzoudis S, Pilpilidis I, Zavos C, Kountouras J. Risk factors for therapeutic ERCP-related complications: an analysis of 2,715 cases performed by a single endoscopist. Ann Gastroenterol. 2014;27(1):65-72.
PMID: 24714755
responsible party type: Sponsor-Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Gulsah Karaoren
investigator title: MD
sharing ipd: Yes
ipd description: The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.