<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/NCT02262845</url>
  </required_header>
  <id_info>
    <org_study_id>90987979</org_study_id>
    <nct_id>NCT02262845</nct_id>
  </id_info>
  <brief_title>Short Term Pancreatic Stenting Registry</brief_title>
  <official_title>A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</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 document clinical utility and distribution of indications for&#xD;
      short term pancreatic stenting, and stent type preference by indication at tertiary referral&#xD;
      centers with expertise in pancreatic endotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as an all-comer, prospective, multi-center, consecutive cohort series,&#xD;
      open-label study.&#xD;
&#xD;
      Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used&#xD;
      per standard of practice to facilitate pancreatic duct drainage in the following clinical&#xD;
      presentations:&#xD;
&#xD;
        -  Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis&#xD;
           post-endoscopic retrograde cholangiopancreatography (ERCP)&#xD;
&#xD;
        -  Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct&#xD;
           stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris,&#xD;
           possibly, but not exclusively before or after ESWL or before pancreatic surgery&#xD;
&#xD;
        -  Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak&#xD;
&#xD;
        -  Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or&#xD;
           strictures after resection of a pancreatic lesion close to the main pancreatic duct or&#xD;
           at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy&#xD;
&#xD;
        -  Group E: Other - In subjects with other indications&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Weeks</target_duration>
  <primary_outcome>
    <measure>Clinical Success: Group A (PEP Risk)</measure>
    <time_frame>Stent placement through 48 hours post stent placement</time_frame>
    <description>Absence of acute pancreatitis from stent placement through 48 hours post stent placement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Success: Group B (Impaired Pancreatic Duct Drainage)</measure>
    <time_frame>Stent placement through stent removal</time_frame>
    <description>Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Success: Group C (Pancreatic Duct Leak):</measure>
    <time_frame>Stent Removal</time_frame>
    <description>Resolution of pancreatic duct leak at stent removal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Success: Group D (Post Pancreatic Surgery)</measure>
    <time_frame>Stent Removal</time_frame>
    <description>Absence of pancreatic duct leak and stricture at stent removal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Sucess: Group E (Other)</measure>
    <time_frame>Stent Removal</time_frame>
    <description>Resolution of the indication for stent placement at stent removal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events and all occurrences of acute pancreatitis</measure>
    <time_frame>Through end of study</time_frame>
    <description>Occurrence and severity of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable and all occurrences of acute pancreatitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Stent Placement</time_frame>
    <description>Evaluation of technical success defined as the ability to place the stent in a satisfactory position in the main pancreatic duct as determined by fluoroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of use</measure>
    <time_frame>Stent Placement</time_frame>
    <description>Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Removability</measure>
    <time_frame>Stent Removal</time_frame>
    <description>Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Migration</measure>
    <time_frame>Through end of study</time_frame>
    <description>Documentation of stent migration rates overall, by Group, and by stent type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reintervention</measure>
    <time_frame>Through end of study</time_frame>
    <description>Evaluation of the occurrence of reintervention defined as any type of endoscopic, percutaneous, or surgical procedure to aid drainage of the pancreas after initial stent placement through end of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent type preference</measure>
    <time_frame>Stent Placement</time_frame>
    <description>Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">246</enrollment>
  <condition>Post-ERCP Acute Pancreatitis</condition>
  <condition>Pancreatic Duct Stricture</condition>
  <condition>Pancreatic Duct Stones</condition>
  <condition>Pancreatic Duct Leakage</condition>
  <arm_group>
    <arm_group_label>Group A: PEP Risk</arm_group_label>
    <description>In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Impaired Pancreatic Duct Drainage</arm_group_label>
    <description>In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C: Pancreatic Duct Leak</arm_group_label>
    <description>In subjects with a pancreatic duct leak</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D: Post Pancreatic Surgery</arm_group_label>
    <description>In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E: Other</arm_group_label>
    <description>In subjects with other indications</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers</intervention_name>
    <description>Used to drain pancreatic ducts</description>
    <arm_group_label>Group A: PEP Risk</arm_group_label>
    <arm_group_label>Group B: Impaired Pancreatic Duct Drainage</arm_group_label>
    <arm_group_label>Group C: Pancreatic Duct Leak</arm_group_label>
    <arm_group_label>Group D: Post Pancreatic Surgery</arm_group_label>
    <arm_group_label>Group E: Other</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will examine how well the Advanix Pancreatic stent helps drainage of the&#xD;
        pancreas when used per standard-of-practice in many different situations.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects age 18 or older.&#xD;
&#xD;
          2. Subjects who require pancreatic drainage and are amenable to endoscopic techniques.&#xD;
&#xD;
          3. Subjects willing and able to comply with the study procedures and follow up schedule&#xD;
             and willing to provide written informed consent to participate in the study.&#xD;
&#xD;
          4. Subjects satisfying at least one of the following clinical presentations:&#xD;
&#xD;
               1. high risk of acute pancreatitis post ERCP&#xD;
&#xD;
               2. impaired pancreatic duct drainage and pain associated with a pancreatic duct&#xD;
                  dominant stricture and/or stones and/or sludge/debris, possibly before ESWL or&#xD;
                  before pancreatic surgery&#xD;
&#xD;
               3. need to maintain proper pancreatic duct drainage in the presence of a pancreatic&#xD;
                  duct leak&#xD;
&#xD;
               4. need to maintain proper pancreatic duct drainage after surgical resection of a&#xD;
                  pancreatic lesion close to the main pancreatic duct or at the level of the&#xD;
                  pancreatico-jejunostomy after pancreatico-duodenectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects for whom endoscopic techniques are contraindicated.&#xD;
&#xD;
          2. Subjects with known sensitivity to any components of the stents or delivery systems.&#xD;
&#xD;
          3. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard&#xD;
             of practice&#xD;
&#xD;
          4. Subjects who are currently enrolled in another investigational study that would&#xD;
             directly interfere with the current study, without prior written approval from the&#xD;
             sponsor.&#xD;
&#xD;
          5. Subjects unable or refusing to comply with the follow-up schedule including subject&#xD;
             living at such a distance from the investigational center that attending follow-up&#xD;
             visits would be unusually difficult or burdensome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Tarnasky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Methodist Dallas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Temple University School of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Dallas Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus Dusseldorf</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40217</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asian Institute of Gastroenterology</name>
      <address>
        <city>Somajiguda</city>
        <state>Hyderabad</state>
        <zip>500 082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>India</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>March 20, 2017</last_update_submitted>
  <last_update_submitted_qc>March 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2017</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>
  <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/NCT02262845
org study id: 90987979
nct id: NCT02262845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to document clinical utility and distribution of indications for
      short term pancreatic stenting, and stent type preference by indication at tertiary referral
      centers with expertise in pancreatic endotherapy.
The study is designed as an all-comer, prospective, multi-center, consecutive cohort series,
      open-label study.

      Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used
      per standard of practice to facilitate pancreatic duct drainage in the following clinical
      presentations:

        -  Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis
           post-endoscopic retrograde cholangiopancreatography (ERCP)

        -  Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct
           stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris,
           possibly, but not exclusively before or after ESWL or before pancreatic surgery

        -  Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak

        -  Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or
           strictures after resection of a pancreatic lesion close to the main pancreatic duct or
           at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy

        -  Group E: Other - In subjects with other indications
observational model: Cohort
time perspective: Prospective
measure: Clinical Success: Group A (PEP Risk)
time frame: Stent placement through 48 hours post stent placement
description: Absence of acute pancreatitis from stent placement through 48 hours post stent placement
measure: Clinical Success: Group B (Impaired Pancreatic Duct Drainage)
time frame: Stent placement through stent removal
description: Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline
measure: Clinical Success: Group C (Pancreatic Duct Leak):
time frame: Stent Removal
description: Resolution of pancreatic duct leak at stent removal
measure: Clinical Success: Group D (Post Pancreatic Surgery)
time frame: Stent Removal
description: Absence of pancreatic duct leak and stricture at stent removal
measure: Clinical Sucess: Group E (Other)
time frame: Stent Removal
description: Resolution of the indication for stent placement at stent removal
measure: Serious Adverse Events and all occurrences of acute pancreatitis
time frame: Through end of study
description: Occurrence and severity of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable and all occurrences of acute pancreatitis.
measure: Technical Success
time frame: Stent Placement
description: Evaluation of technical success defined as the ability to place the stent in a satisfactory position in the main pancreatic duct as determined by fluoroscopy.
measure: Ease of use
time frame: Stent Placement
description: Evaluation of ease of use documenting overall ease of placement, pushability of stent and ability to visualize the stent fluoroscopically.
measure: Removability
time frame: Stent Removal
description: Evaluation of removability defined as ability to remove the Advanix stent endoscopically without serious stent removal related adverse events.
measure: Stent Migration
time frame: Through end of study
description: Documentation of stent migration rates overall, by Group, and by stent type
measure: Reintervention
time frame: Through end of study
description: Evaluation of the occurrence of reintervention defined as any type of endoscopic, percutaneous, or surgical procedure to aid drainage of the pancreas after initial stent placement through end of follow-up.
measure: Stent type preference
time frame: Stent Placement
description: Documenting stent type preference by subject presentation and pancreatic plastic stenting indication.
arm group label: Group A: PEP Risk
description: In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)
arm group label: Group B: Impaired Pancreatic Duct Drainage
description: In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery
arm group label: Group C: Pancreatic Duct Leak
description: In subjects with a pancreatic duct leak
arm group label: Group D: Post Pancreatic Surgery
description: In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
arm group label: Group E: Other
description: In subjects with other indications
intervention type: Device
intervention name: The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers
description: Used to drain pancreatic ducts
arm group label: Group A: PEP Risk
arm group label: Group B: Impaired Pancreatic Duct Drainage
arm group label: Group C: Pancreatic Duct Leak
arm group label: Group D: Post Pancreatic Surgery
arm group label: Group E: Other
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Tarnasky, MD
role: Principal Investigator
affiliation: Methodist Dallas Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: India
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Pancreatitis
sharing ipd: No