<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/NCT03263481</url>
  </required_header>
  <id_info>
    <org_study_id>1203008365</org_study_id>
    <nct_id>NCT03263481</nct_id>
  </id_info>
  <brief_title>Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?</brief_title>
  <acronym>IDST</acronym>
  <official_title>Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as&#xD;
      determined by a 30 minute intraductal secretin stimulation test in patients with a low&#xD;
      likelihood of pancreatic pathology and to compare these data to those obtained from our&#xD;
      historical patients with suspected chronic pancreatitis. These will be patients in which&#xD;
      inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde&#xD;
      cholangiopancreatography (ERCP) for biliary indications . All study subjects will receive a 5&#xD;
      day follow-up phone call. Enrollment goal is 36 subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Secretory flow rates measured by volume</measure>
    <time_frame>5 minutes</time_frame>
    <description>Volume of pancreatic juices will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secretory flow rates measured by volume</measure>
    <time_frame>10 minutes</time_frame>
    <description>Volume of pancreatic juices will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secretory flow rates measured by volume</measure>
    <time_frame>15 minutes</time_frame>
    <description>Volume of pancreatic juices will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secretory flow rates measured by volume</measure>
    <time_frame>20 minutes</time_frame>
    <description>Volume of pancreatic juices will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secretory flow rates measured by volume</measure>
    <time_frame>25 minutes</time_frame>
    <description>Volume of pancreatic juices will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secretory flow rates measured by volume</measure>
    <time_frame>30 minutes</time_frame>
    <description>Volume of pancreatic juices will be collected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bicarbonate concentration of timed pancreatic juice</measure>
    <time_frame>5 minutes</time_frame>
    <description>Concentration of bicarbonate levels will be determined</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bicarbonate concentration of timed pancreatic juice</measure>
    <time_frame>10 minutes</time_frame>
    <description>Concentration of bicarbonate levels will be determined</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bicarbonate concentration of timed pancreatic juice</measure>
    <time_frame>15 minutes</time_frame>
    <description>Concentration of bicarbonate levels will be determined</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bicarbonate concentration of timed pancreatic juice</measure>
    <time_frame>20 minutes</time_frame>
    <description>Concentration of bicarbonate levels will be determined</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bicarbonate concentration of timed pancreatic juice</measure>
    <time_frame>25 minutes</time_frame>
    <description>Concentration of bicarbonate levels will be determined</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bicarbonate concentration of timed pancreatic juice</measure>
    <time_frame>30 minutes</time_frame>
    <description>Concentration of bicarbonate levels will be determined</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Cholangiopancreatography, Endoscopic Retrograde</condition>
  <arm_group>
    <arm_group_label>ERCP with inadvertent pancreatic cannulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects undergoing ERCP for a biliary indication in which inadvertent pancreatic cannulation occurs will undergo intraductal secretin testing per the study protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraductal secretin test (IDST)</intervention_name>
    <description>If pancreatic duct entry incidentally occurs during the clinically scheduled ERCP and the pancreatic duct appears normal, an IDST will be performed for study purposes. An IDST consists of the administration of human secretin, after which pancreatic juice is collected intraductally. In this study, the fluid will be collected through continuous aspiration in 5 minute intervals for 30 minutes. Samples will be collected at 5, 10, 15, 20, 25, and 30 minutes after secretin administration (6 collections in total).</description>
    <arm_group_label>ERCP with inadvertent pancreatic cannulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Male or female patients ≥ 18 years of age referred to Indiana University Health,&#xD;
        University Hospital for ERCP for a biliary indication, at the discretion of the treating MD&#xD;
        (e.g. suspected common bile duct stone, initial post-liver transplant evaluation, suspected&#xD;
        or confirmed cholangiocarcinoma, suspected primary sclerosing cholangitis -- see exclusion&#xD;
        criterion #12)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant woman or breast feeding&#xD;
&#xD;
          2. Age &lt;18 years&#xD;
&#xD;
          3. Patient unable to give informed consent&#xD;
&#xD;
          4. Patient with a history of pancreatic surgery&#xD;
&#xD;
          5. Patient with a history of pancreatic cancer&#xD;
&#xD;
          6. Patient with a history of acute or chronic pancreatitis&#xD;
&#xD;
          7. Patient with radiographic evidence of acute or chronic pancreatitis on CT, MRCP, or&#xD;
             EUS&#xD;
&#xD;
          8. Patient with a current or prior history of average daily alcohol consumption of&#xD;
             greater than 60 g per day for more than 2 years&#xD;
&#xD;
          9. Patient with a history of cigarette smoking greater that 20 pack-years&#xD;
&#xD;
         10. Patient with a history of pancreas divisum&#xD;
&#xD;
         11. Evidence of chronic pancreatitis on pancreatogram during ERCP&#xD;
&#xD;
         12. ERCP for an isolated biliary indication with previous biliary sphincterotomy or for&#xD;
             biliary stent exchange, when pancreatic entry should easily be avoided by the&#xD;
             endoscopist.&#xD;
&#xD;
         13. History of allergy or adverse reactions to secretin&#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>Evan L Fogel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>September 4, 2023</last_update_submitted>
  <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Evan Fogel</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Secretin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03263481
org study id: 1203008365
nct id: NCT03263481
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as
      determined by a 30 minute intraductal secretin stimulation test in patients with a low
      likelihood of pancreatic pathology and to compare these data to those obtained from our
      historical patients with suspected chronic pancreatitis. These will be patients in which
      inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde
      cholangiopancreatography (ERCP) for biliary indications . All study subjects will receive a 5
      day follow-up phone call. Enrollment goal is 36 subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Secretory flow rates measured by volume
time frame: 5 minutes
description: Volume of pancreatic juices will be collected
measure: Secretory flow rates measured by volume
time frame: 10 minutes
description: Volume of pancreatic juices will be collected
measure: Secretory flow rates measured by volume
time frame: 15 minutes
description: Volume of pancreatic juices will be collected
measure: Secretory flow rates measured by volume
time frame: 20 minutes
description: Volume of pancreatic juices will be collected
measure: Secretory flow rates measured by volume
time frame: 25 minutes
description: Volume of pancreatic juices will be collected
measure: Secretory flow rates measured by volume
time frame: 30 minutes
description: Volume of pancreatic juices will be collected
measure: Bicarbonate concentration of timed pancreatic juice
time frame: 5 minutes
description: Concentration of bicarbonate levels will be determined
measure: Bicarbonate concentration of timed pancreatic juice
time frame: 10 minutes
description: Concentration of bicarbonate levels will be determined
measure: Bicarbonate concentration of timed pancreatic juice
time frame: 15 minutes
description: Concentration of bicarbonate levels will be determined
measure: Bicarbonate concentration of timed pancreatic juice
time frame: 20 minutes
description: Concentration of bicarbonate levels will be determined
measure: Bicarbonate concentration of timed pancreatic juice
time frame: 25 minutes
description: Concentration of bicarbonate levels will be determined
measure: Bicarbonate concentration of timed pancreatic juice
time frame: 30 minutes
description: Concentration of bicarbonate levels will be determined
arm group label: ERCP with inadvertent pancreatic cannulation
arm group type: Experimental
description: Subjects undergoing ERCP for a biliary indication in which inadvertent pancreatic cannulation occurs will undergo intraductal secretin testing per the study protocol.
intervention type: Procedure
intervention name: Intraductal secretin test (IDST)
description: If pancreatic duct entry incidentally occurs during the clinically scheduled ERCP and the pancreatic duct appears normal, an IDST will be performed for study purposes. An IDST consists of the administration of human secretin, after which pancreatic juice is collected intraductally. In this study, the fluid will be collected through continuous aspiration in 5 minute intervals for 30 minutes. Samples will be collected at 5, 10, 15, 20, 25, and 30 minutes after secretin administration (6 collections in total).
arm group label: ERCP with inadvertent pancreatic cannulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evan L Fogel, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Evan Fogel
investigator title: Professor of Medicine
mesh term: Secretin