<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/NCT03022110</url>
  </required_header>
  <id_info>
    <org_study_id>2017010301</org_study_id>
    <nct_id>NCT03022110</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts</brief_title>
  <official_title>Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yiqi Du</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and&#xD;
      traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the&#xD;
      cyst recurrence rate of 12 months after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria&#xD;
&#xD;
        1. Subject with ages from 18-80 years old&#xD;
&#xD;
        2. Subject with pancreatic pseudocysts confirmed by CT&#xD;
&#xD;
        3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months&#xD;
&#xD;
        4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall&#xD;
&#xD;
        5. Subject has the symptoms related with the pseudocyst&#xD;
&#xD;
        6. The consent form has been signed&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
        1. Subject is younger than 18 years or older than 80 years&#xD;
&#xD;
        2. Pancreatic pseudocyst communicate with the main pancreatic duct&#xD;
&#xD;
        3. Subject can't accept the endoscopic procedure&#xD;
&#xD;
        4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess&#xD;
&#xD;
        5. The distance between gastric and the wall of the pseudocyst is more than 1 cm&#xD;
&#xD;
        6. Subject with 2 or more than 2 cysts&#xD;
&#xD;
        7. Subject has blood coagulation dysfunction&#xD;
&#xD;
        8. Pregnant or subject has mental disorders&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cyst recurrence rate</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success rate</measure>
    <time_frame>up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Pancreatic Pseudocyst</condition>
  <arm_group>
    <arm_group_label>plastic stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic Ultrasound-guided Drainage with plastic stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lumen-apposing metal stent (LAMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic Ultrasound-guided Drainage</intervention_name>
    <description>Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound</description>
    <arm_group_label>lumen-apposing metal stent (LAMS)</arm_group_label>
    <arm_group_label>plastic stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject with ages from 18-80 years old&#xD;
&#xD;
          2. Subject with pancreatic pseudocysts confirmed by CT&#xD;
&#xD;
          3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months&#xD;
&#xD;
          4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall&#xD;
&#xD;
          5. Subject has the symptoms related with the pseudocyst&#xD;
&#xD;
          6. The consent form has been signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is younger than 18 years or older than 80 years&#xD;
&#xD;
          2. Pancreatic pseudocyst communicate with the main pancreatic duct&#xD;
&#xD;
          3. Subject can't accept the endoscopic procedure&#xD;
&#xD;
          4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess&#xD;
&#xD;
          5. The distance between gastric and the wall of the pseudocyst is more than 1 cm&#xD;
&#xD;
          6. Subject with 2 or more than 2 cysts&#xD;
&#xD;
          7. Subject has blood coagulation dysfunction&#xD;
&#xD;
          8. Pregnant or subject has mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Yiqi Du</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Pseudocyst</mesh_term>
  </condition_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/NCT03022110
org study id: 2017010301
nct id: NCT03022110
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and
      traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the
      cyst recurrence rate of 12 months after treatment.
Inclusion criteria

        1. Subject with ages from 18-80 years old

        2. Subject with pancreatic pseudocysts confirmed by CT

        3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months

        4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall

        5. Subject has the symptoms related with the pseudocyst

        6. The consent form has been signed

      Exclusion criteria

        1. Subject is younger than 18 years or older than 80 years

        2. Pancreatic pseudocyst communicate with the main pancreatic duct

        3. Subject can't accept the endoscopic procedure

        4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess

        5. The distance between gastric and the wall of the pseudocyst is more than 1 cm

        6. Subject with 2 or more than 2 cysts

        7. Subject has blood coagulation dysfunction

        8. Pregnant or subject has mental disorders
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cyst recurrence rate
time frame: up to 12 months
measure: Technical success rate
time frame: up to 48 hours
measure: Clinical success rate
time frame: up to 12 months
measure: Complication rate
time frame: up to 12 months
arm group label: plastic stent
arm group type: Active Comparator
description: Endoscopic Ultrasound-guided Drainage with plastic stent
arm group label: lumen-apposing metal stent (LAMS)
arm group type: Experimental
description: Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent
intervention type: Device
intervention name: Endoscopic Ultrasound-guided Drainage
description: Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound
arm group label: lumen-apposing metal stent (LAMS)
arm group label: plastic stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Changhai Hospital
investigator full name: Yiqi Du
investigator title: Professor
mesh term: Pancreatic Pseudocyst
sharing ipd: No