<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/NCT03027895</url>
  </required_header>
  <id_info>
    <org_study_id>2017010302</org_study_id>
    <nct_id>NCT03027895</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)</brief_title>
  <official_title>Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and&#xD;
      double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis&#xD;
      (WON), mainly to observe the efficacy and safety of LAMS for WON.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient with pancreatic walled-off necrosis (WON) would be treated randomized with&#xD;
      lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance&#xD;
      of Endoscopic Ultrasonography. The investigators compare the effect of the two stents,&#xD;
      including technical success, clinical success, adverse event, recurrence, and so on.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>clinical success</measure>
    <time_frame>uo to 1 months</time_frame>
    <description>The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>up to 2months/ stent remove</time_frame>
    <description>any adverse event occured after stent inserted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>up to 12 months</time_frame>
    <description>After the clinical success, imaging examination show cyst again and accompanied by symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>technical success</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Stent placed through the wall bracket and pancreatic pseudocyst successfully</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">256</enrollment>
  <condition>Pancreatic Pseudocyst</condition>
  <arm_group>
    <arm_group_label>Lumen-apposing metal stent(LAMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double pigtail plastic stent(DPPS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lumen-apposing metal stent (LAMS)</intervention_name>
    <description>Endoscopic Ultrasound-guided Drainage of WON with LAMS</description>
    <arm_group_label>Lumen-apposing metal stent(LAMS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double pigtail plastic stent (DPPS)</intervention_name>
    <description>Endoscopic Ultrasound-guided Drainage of WON with DPPS</description>
    <arm_group_label>Double pigtail plastic stent(DPPS)</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>March 2018</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>March 28, 2018</last_update_submitted>
  <last_update_submitted_qc>March 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2018</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>
    <mesh_term>Necrosis</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/NCT03027895
org study id: 2017010302
nct id: NCT03027895
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and
      double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis
      (WON), mainly to observe the efficacy and safety of LAMS for WON.
Patient with pancreatic walled-off necrosis (WON) would be treated randomized with
      lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance
      of Endoscopic Ultrasonography. The investigators compare the effect of the two stents,
      including technical success, clinical success, adverse event, recurrence, and so on.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical success
time frame: uo to 1 months
description: The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
measure: adverse event
time frame: up to 2months/ stent remove
description: any adverse event occured after stent inserted
measure: recurrence rate
time frame: up to 12 months
description: After the clinical success, imaging examination show cyst again and accompanied by symptoms
measure: technical success
time frame: up to 48 hours
description: Stent placed through the wall bracket and pancreatic pseudocyst successfully
arm group label: Lumen-apposing metal stent(LAMS)
arm group type: Experimental
description: Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
arm group label: Double pigtail plastic stent(DPPS)
arm group type: Active Comparator
description: Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
intervention type: Device
intervention name: Lumen-apposing metal stent (LAMS)
description: Endoscopic Ultrasound-guided Drainage of WON with LAMS
arm group label: Lumen-apposing metal stent(LAMS)
intervention type: Device
intervention name: Double pigtail plastic stent (DPPS)
description: Endoscopic Ultrasound-guided Drainage of WON with DPPS
arm group label: Double pigtail plastic stent(DPPS)
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
mesh term: Necrosis
sharing ipd: No