<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/NCT03002051</url>
  </required_header>
  <id_info>
    <org_study_id>SPAXUS version 3.0</org_study_id>
    <nct_id>NCT03002051</nct_id>
  </id_info>
  <brief_title>EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent</brief_title>
  <official_title>EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SoonChunHyang University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided&#xD;
      transenteric drainage of PFC or of biliary tree including GB&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with the following conditions would be recruited for drainage under EUS guidance&#xD;
      with the new lumen apposing FCSEMS&#xD;
&#xD;
        -  Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or&#xD;
           10 mm)&#xD;
&#xD;
        -  Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)&#xD;
&#xD;
        -  Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)&#xD;
&#xD;
        -  Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)&#xD;
&#xD;
        -  Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary&#xD;
           approach (the diameter of the CBD &gt; 10 mm) (SPAXUS 8 or 10 mm)&#xD;
&#xD;
      Outcome paramaters include technical and clinical success, adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical success for pancreatic fluid collections</measure>
    <time_frame>8 hrs</time_frame>
    <description>① Clinical success of pancreatic fluid collections&#xD;
Peudocyst: resolution more than 50% in the initial size of cyst.&#xD;
Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success for acute cholecystitis</measure>
    <time_frame>8hrs</time_frame>
    <description>- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success for obstructive jaundice</measure>
    <time_frame>2 weeks</time_frame>
    <description>- A decrease in total bilirubin to &lt; 50 % of the pre-stenting value within 2 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Techincal success</measure>
    <time_frame>1 day</time_frame>
    <description>- Satisfactory access, placement of stent and drainage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 day</time_frame>
    <description>Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation.&#xD;
Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs.&#xD;
Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study.&#xD;
Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Pancreatic Pseudocyst</condition>
  <condition>Pancreatic Necrosis</condition>
  <condition>Biliary Obstruction</condition>
  <condition>Acute Cholecystitis</condition>
  <arm_group>
    <arm_group_label>EUS guided drainage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EUS-guided drainage</intervention_name>
    <description>Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage.&#xD;
EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen.&#xD;
After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm).&#xD;
After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen.&#xD;
After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance.</description>
    <arm_group_label>EUS guided drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient must meet all of the following inclusion criteria to be eligible for enrollment&#xD;
        into the study.&#xD;
&#xD;
          -  Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage&#xD;
&#xD;
          -  The patient who aged from 20 to 80 years. Legally acceptable representative must be&#xD;
             capable of giving written informed consent prior to participation in this study&#xD;
&#xD;
          -  Target lesion that is accessible through the transenteric approach&#xD;
&#xD;
          -  The woman of child-bearing age must be negative from the pregnancy test in order to&#xD;
             participate in this study&#xD;
&#xD;
          -  The patient who is willing and able to comply with the scheduled visits, treatment&#xD;
             plan, laboratory tests, and other study procedures&#xD;
&#xD;
          -  The patients should not have any unacceptable conditions (e.g., physiological,&#xD;
             familyism, social, geographical) for medical follow-up and adaptation of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient presenting with any of the following will not be included in the study.&#xD;
&#xD;
          -  Inaccessible to EUS-guided approach&#xD;
&#xD;
          -  Bleeding tendency: International normalized ratio (INR) of prothrombin time &lt; 1.5 or&#xD;
             platelet conunt &lt; 60,000/mm3&#xD;
&#xD;
          -  Patients with Disseminated Intravascular Coagulation syndrome(DIC)&#xD;
&#xD;
          -  Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin,&#xD;
             Wafarin etc.)&#xD;
&#xD;
          -  Patients with other serious disease or medical condition&#xD;
&#xD;
          -  Patients with past medical history of significant neurologic or Psychiatric disorders&#xD;
             such as dementia or seizure&#xD;
&#xD;
          -  Unstable heart disease despite of treatment, recent myocardial infarction within 6&#xD;
             month (Even though MI was diagnosed within 6 months, if it becomes stable presently,&#xD;
             the patient can be possible to participate).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Teoh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 12, 2019</last_update_submitted>
  <last_update_submitted_qc>December 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Anthony Teoh</investigator_full_name>
    <investigator_title>Associate 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>Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</mesh_term>
    <mesh_term>Pancreatitis, Acute Necrotizing</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/NCT03002051
org study id: SPAXUS version 3.0
nct id: NCT03002051
lead sponsor: 
collaborator: 
has dmc: Yes
To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided
      transenteric drainage of PFC or of biliary tree including GB
Patients with the following conditions would be recruited for drainage under EUS guidance
      with the new lumen apposing FCSEMS

        -  Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or
           10 mm)

        -  Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)

        -  Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)

        -  Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)

        -  Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary
           approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm)

      Outcome paramaters include technical and clinical success, adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical success for pancreatic fluid collections
time frame: 8 hrs
description: ① Clinical success of pancreatic fluid collections
Peudocyst: resolution more than 50% in the initial size of cyst.
Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
measure: Clinical success for acute cholecystitis
time frame: 8hrs
description: - Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.
measure: Clinical success for obstructive jaundice
time frame: 2 weeks
description: - A decrease in total bilirubin to < 50 % of the pre-stenting value within 2 weeks.
measure: Techincal success
time frame: 1 day
description: - Satisfactory access, placement of stent and drainage.
measure: Adverse events
time frame: 30 day
description: Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation.
Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs.
Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study.
Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study
arm group label: EUS guided drainage
arm group type: Experimental
description: Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent
intervention type: Device
intervention name: EUS-guided drainage
description: Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage.
EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen.
After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm).
After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen.
After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance.
arm group label: EUS guided drainage
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anthony Teoh
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Anthony Teoh
investigator title: Associate Professor
mesh term: Pancreatic Pseudocyst
mesh term: Cholecystitis
mesh term: Cholecystitis, Acute
mesh term: Pancreatitis, Acute Necrotizing
mesh term: Necrosis
sharing ipd: No