<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/NCT03775681</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0545</org_study_id>
    <secondary_id>NCI-2018-03163</secondary_id>
    <secondary_id>2018-0545</secondary_id>
    <nct_id>NCT03775681</nct_id>
  </id_info>
  <brief_title>Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders</brief_title>
  <official_title>Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway)&#xD;
      when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for&#xD;
      pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients&#xD;
      breathe while they are asleep during procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the successful completion of endoscopic retrograde cholangiopancreatography&#xD;
      (ERCP) with the Laryngeal Mask Airway (LMA) Gastro.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine gastroenterologist satisfaction with the LMA Gastro.&#xD;
&#xD;
      II. To determine anesthesia provider satisfaction with the LMA Gastro.&#xD;
&#xD;
      III. To determine the rate of unsuccessful LMA Gastro placement.&#xD;
&#xD;
      IV. To determine the ability of LMA Gastro to provide adequate oxygenation and ventilation&#xD;
      throughout the procedure.&#xD;
&#xD;
      V. To determine and describe the rate of adverse events.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients wear Laryngeal Mask Airway Gastro after receiving general anesthesia and falling&#xD;
      asleep. Patients then undergo standard of care endoscopic retrograde&#xD;
      cholangiopancreatography. Patients also complete a 5-minute interview following ERCP&#xD;
      procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Participants With Overall Success of ERCP With LMA Gastro</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Successful completion of ERCP with the LMA® Gastro™</description>
  </primary_outcome>
  <other_outcome>
    <measure>Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Bile Duct Disorder</condition>
  <condition>Endocrine Pancreas Disorder</condition>
  <arm_group>
    <arm_group_label>Device feasibility (Laryngeal Mask Airway, ERCP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Retrograde Cholangiopancreatography</intervention_name>
    <description>Undergo standard of care ERCP</description>
    <arm_group_label>Device feasibility (Laryngeal Mask Airway, ERCP)</arm_group_label>
    <other_name>ERCP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Device feasibility (Laryngeal Mask Airway, ERCP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal Mask Airway</intervention_name>
    <description>Wear LMA</description>
    <arm_group_label>Device feasibility (Laryngeal Mask Airway, ERCP)</arm_group_label>
    <other_name>Laryngeal Mask; LMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing elective ERCP with general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with propofol allergy&#xD;
&#xD;
          -  Patients at increased aspiration risk&#xD;
&#xD;
          -  Patients with abnormal head/neck pathology preventing LMA Gastro placement&#xD;
&#xD;
          -  Patients with surgical or radiation treatment to the head/neck making LMA Gastro&#xD;
             placement difficult&#xD;
&#xD;
          -  Esophagectomy patients&#xD;
&#xD;
          -  Patients already intubated upon arrival to endoscopy suite&#xD;
&#xD;
          -  Patients undergoing endoscopic ultrasound (EUS)&#xD;
&#xD;
          -  Patients with body mass index (BMI) 35 kg/m^2&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Hagan</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <results_first_submitted>January 13, 2021</results_first_submitted>
  <results_first_submitted_qc>March 31, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2021</results_first_posted>
  <last_update_submitted>March 31, 2021</last_update_submitted>
  <last_update_submitted_qc>March 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bile Duct Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03775681/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Period: January 2019 to July 2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>LMA® Gastro™</title>
          <description>Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Race and Ethnicity was not the criteria for Inclusion in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>LMA® Gastro™</title>
          <description>Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" lower_limit="44" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Race and Ethnicity was not the criteria for Inclusion in the study.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Race and Ethnicity was not the criteria for Inclusion in the study.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Race and Ethnicity was not the criteria for Inclusion in the study.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Endoscopic Retrograde Cholangiopancreatography (ERCP)</title>
          <description>Type of ERCP cases involving the use of LMA Gastro</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Stent Placement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Removal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stent Exchange</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diagnostic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants With Overall Success of ERCP With LMA Gastro</title>
        <description>Successful completion of ERCP with the LMA® Gastro™</description>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LMA® Gastro™</title>
            <description>Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Overall Success of ERCP With LMA Gastro</title>
          <description>Successful completion of ERCP with the LMA® Gastro™</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™</title>
        <description>Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.</description>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LMA® Gastro™</title>
            <description>Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.</description>
          </group>
        </group_list>
        <measure>
          <title>Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™</title>
          <description>Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discordance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.45" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Concordance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.55" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline</time_frame>
      <desc>This is a non-randomized, unblinded feasibility study involving use of LMA Gastro device for ERCP. The device has been deemed low risk and there are no additional risk to the patient. No AE/SAE's to report.</desc>
      <group_list>
        <group group_id="E1">
          <title>LMA® Gastro™</title>
          <description>Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Katherine Hagan, Associate Professor, Anesthesiology &amp; PeriOper Med</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(713) 794-5945</phone>
      <email>khagan@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03775681
org study id: 2018-0545
secondary id: NCI-2018-03163
secondary id: 2018-0545
nct id: NCT03775681
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway)
      when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for
      pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients
      breathe while they are asleep during procedures.
PRIMARY OBJECTIVES:

      I. To determine the successful completion of endoscopic retrograde cholangiopancreatography
      (ERCP) with the Laryngeal Mask Airway (LMA) Gastro.

      SECONDARY OBJECTIVES:

      I. To determine gastroenterologist satisfaction with the LMA Gastro.

      II. To determine anesthesia provider satisfaction with the LMA Gastro.

      III. To determine the rate of unsuccessful LMA Gastro placement.

      IV. To determine the ability of LMA Gastro to provide adequate oxygenation and ventilation
      throughout the procedure.

      V. To determine and describe the rate of adverse events.

      OUTLINE:

      Patients wear Laryngeal Mask Airway Gastro after receiving general anesthesia and falling
      asleep. Patients then undergo standard of care endoscopic retrograde
      cholangiopancreatography. Patients also complete a 5-minute interview following ERCP
      procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The Number of Participants With Overall Success of ERCP With LMA Gastro
time frame: Up to 3 months
description: Successful completion of ERCP with the LMA® Gastro™
measure: Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™
time frame: Up to 3 months
description: Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.
arm group label: Device feasibility (Laryngeal Mask Airway, ERCP)
arm group type: Experimental
description: Patients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.
intervention type: Procedure
intervention name: Endoscopic Retrograde Cholangiopancreatography
description: Undergo standard of care ERCP
arm group label: Device feasibility (Laryngeal Mask Airway, ERCP)
other name: ERCP
intervention type: Other
intervention name: Interview
description: Ancillary studies
arm group label: Device feasibility (Laryngeal Mask Airway, ERCP)
intervention type: Device
intervention name: Laryngeal Mask Airway
description: Wear LMA
arm group label: Device feasibility (Laryngeal Mask Airway, ERCP)
other name: Laryngeal Mask; LMA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine Hagan
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Bile Duct Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 