<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/NCT03756116</url>
  </required_header>
  <id_info>
    <org_study_id>PEP-17-07</org_study_id>
    <nct_id>NCT03756116</nct_id>
  </id_info>
  <brief_title>Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide</brief_title>
  <official_title>Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Sublingual Nitroglycerin: A Multi-center, Single-blind, Randomized Controlled Trial</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>
      Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most&#xD;
      common complication with high costs, significant morbidity and even mortality. The major&#xD;
      mechanisms of PEP is the papillary edema which is caused by manipulations during cannulation&#xD;
      or endoscopic treatment. The papillary edema may cause temporary outflow obstruction of&#xD;
      pancreatic juice, and then increase ductal pressure, resulting in the occurrence of&#xD;
      pancreatitis. Nitroglycerin can reduce the Oddis sphincter tension, the internal pressure of&#xD;
      the biliary tract and the pancreatic duct. Therefore, it is widely used in clinical to&#xD;
      prevent and treat pancreatitis. Many studies found nitroglycerin might be effective in&#xD;
      preventing PEP. And topical application of epinephrine on the papilla may reduce papillary&#xD;
      edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. There are&#xD;
      reports that epinephrine sprayed on the papilla may be effective to prevent PEP.&#xD;
&#xD;
      The investigators therefore designed a prospective randomized trial to determine whether&#xD;
      routine using papillary epinephrine spraying in patients received octreotide can reduce&#xD;
      post-ERCP pancreatitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of post-ERCP pancreatitis in the groups</measure>
    <time_frame>48 hours after ERCP</time_frame>
    <description>The primary outcome is the incidence of PEP as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc, and 2) amylase or lipase ≥ 3x the upper limit of normal 48 hours after the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Others complications</measure>
    <time_frame>1 weeks after ERCP</time_frame>
    <description>Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation，et al.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Post-ERCP Acute Pancreatitis</condition>
  <condition>Epinephrine</condition>
  <arm_group>
    <arm_group_label>Epinephrine sprayed on the papilla</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline sprayed on the papilla</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope; followed by octreotide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epinephrine sprayed on the papilla</intervention_name>
    <description>Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.</description>
    <arm_group_label>Epinephrine sprayed on the papilla</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Saline sprayed on the papilla</intervention_name>
    <description>Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope.</description>
    <arm_group_label>Saline sprayed on the papilla</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ERCP surgery is required&#xD;
&#xD;
          2. Signed inform consent form and agreed to follow-up on time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute pancreatitis.&#xD;
&#xD;
          2. Pregnancy or history of allergy to epinephrine.&#xD;
&#xD;
          3. Serious liver, kidney, heart and coagulation disorders&#xD;
&#xD;
          4. Unwilling or inability to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miao Lin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Miao Lin</last_name>
    <phone>086-25-58509932</phone>
    <email>miaolinxh@163.com</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Miao, MD</last_name>
      <phone>086-25-58509932</phone>
      <email>miaolinxh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</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>Pancreatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</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/NCT03756116
org study id: PEP-17-07
nct id: NCT03756116
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most
      common complication with high costs, significant morbidity and even mortality. The major
      mechanisms of PEP is the papillary edema which is caused by manipulations during cannulation
      or endoscopic treatment. The papillary edema may cause temporary outflow obstruction of
      pancreatic juice, and then increase ductal pressure, resulting in the occurrence of
      pancreatitis. Nitroglycerin can reduce the Oddis sphincter tension, the internal pressure of
      the biliary tract and the pancreatic duct. Therefore, it is widely used in clinical to
      prevent and treat pancreatitis. Many studies found nitroglycerin might be effective in
      preventing PEP. And topical application of epinephrine on the papilla may reduce papillary
      edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. There are
      reports that epinephrine sprayed on the papilla may be effective to prevent PEP.

      The investigators therefore designed a prospective randomized trial to determine whether
      routine using papillary epinephrine spraying in patients received octreotide can reduce
      post-ERCP pancreatitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of post-ERCP pancreatitis in the groups
time frame: 48 hours after ERCP
description: The primary outcome is the incidence of PEP as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc, and 2) amylase or lipase ≥ 3x the upper limit of normal 48 hours after the procedure.
measure: Others complications
time frame: 1 weeks after ERCP
description: Others complications are the cute cholecystitia, acute cholangitis,hemorrhage and perforation，et al.
arm group label: Epinephrine sprayed on the papilla
arm group type: Experimental
description: Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.
arm group label: Saline sprayed on the papilla
arm group type: Active Comparator
description: Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope; followed by octreotide.
intervention type: Procedure
intervention name: Epinephrine sprayed on the papilla
description: Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.
arm group label: Epinephrine sprayed on the papilla
intervention type: Procedure
intervention name: Saline sprayed on the papilla
description: Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope.
arm group label: Saline sprayed on the papilla
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Miao Lin
role: Principal Investigator
affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
last name: Miao Lin
phone: 086-25-58509932
email: miaolinxh@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Epinephrine