<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/NCT02992678</url>
  </required_header>
  <id_info>
    <org_study_id>pentoxifylline-001</org_study_id>
    <nct_id>NCT02992678</nct_id>
  </id_info>
  <brief_title>Pentoxifylline for the Prevention of PEP</brief_title>
  <official_title>Prophylactic Treatment Pentoxifylline for the Prevention of Post-ERCP Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anhui Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anhui Provincial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are&#xD;
      scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be&#xD;
      recruited for the study. Patients were randomized using opaque, sealed envelopes containing&#xD;
      random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo&#xD;
      (placebo group) for preventing ERCP pancreatitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Early Phase 1</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Pancreatitis</measure>
    <time_frame>24 hours</time_frame>
    <description>If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours, patients also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP (post-ERCP pancreatitis).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The prophylaxis effect of pentoxifylline on post-ERCP pancreatitis in higher risk patients</measure>
    <time_frame>24 hours</time_frame>
    <description>If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Pentoxifylline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pentoxifylline</intervention_name>
    <description>Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.</description>
    <arm_group_label>Pentoxifylline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females, age &gt; 18 years.&#xD;
&#xD;
          2. Normal amylase level before undergoing ERCP.&#xD;
&#xD;
          3. Signed inform consent form and agreed to follow-up on time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical or psychological condition that would not permit the patient to complete the&#xD;
             study or sign the informed consent.&#xD;
&#xD;
          2. Patients involved in other study within 60 days.&#xD;
&#xD;
          3. Billroth II or Roux-en-Y anatomy&#xD;
&#xD;
          4. Acute pancreatitis.&#xD;
&#xD;
          5. a history of previous ERCP&#xD;
&#xD;
          6. Pregnancy or history of allergy to pentoxifylline&#xD;
&#xD;
          7. Patient treated for arterial hypertension&#xD;
&#xD;
          8. Patient with severe coagulopathy&#xD;
&#xD;
          9. Patient with hyper sensibility of pentoxifylline&#xD;
&#xD;
         10. Nursing mothers&#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>Shao Feng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shao Feng, MD</last_name>
    <phone>8613033090788</phone>
    <email>tagsmile1985@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University</name>
      <address>
        <city>HeFei</city>
        <state>Anhui</state>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shao Feng, MD</last_name>
      <phone>8613033090788</phone>
      <email>tagsmile1985@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</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>Pentoxifylline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02992678
org study id: pentoxifylline-001
nct id: NCT02992678
lead sponsor: 
has dmc: Yes
Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are
      scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be
      recruited for the study. Patients were randomized using opaque, sealed envelopes containing
      random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo
      (placebo group) for preventing ERCP pancreatitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Acute Pancreatitis
time frame: 24 hours
description: If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours, patients also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP (post-ERCP pancreatitis).
measure: The prophylaxis effect of pentoxifylline on post-ERCP pancreatitis in higher risk patients
time frame: 24 hours
description: If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis).
arm group label: Pentoxifylline
arm group type: Experimental
description: Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.
intervention type: Drug
intervention name: Pentoxifylline
description: Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
arm group label: Pentoxifylline
intervention type: Drug
intervention name: Placebo
description: Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shao Feng, MD
role: Principal Investigator
affiliation: Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
last name: Shao Feng, MD
phone: 8613033090788
email: tagsmile1985@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Pentoxifylline
sharing ipd: No