<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/NCT04503291</url>
  </required_header>
  <id_info>
    <org_study_id>BucheonStMarys</org_study_id>
    <nct_id>NCT04503291</nct_id>
  </id_info>
  <brief_title>Comparison Between Transpapillary and Suprapapillary Metal Stent</brief_title>
  <official_title>Comparison Between Transpapillary and Suprapapillary Metal Stent Placement With Endoscopic Sphincterotomy in Common Bile Duct Malignant Obstruction: Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bucheon St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Incheon St.Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St Vincent's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bucheon St. Mary's Hospital</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>
      If surgical treatment is not possible in patients with malignant obstruction in the common&#xD;
      bile duct, placing metal stents using endoscopy is a standardized treatment to resolve&#xD;
      biliary obstruction. The metal stent is located in the bile duct to cover the stenotic&#xD;
      portion by malignant tumors.&#xD;
&#xD;
      The lower end of the metal stent can be located inside the common bile duct above the major&#xD;
      ampulla or in the duodenum through the major ampulla. These two procedures with supra- or&#xD;
      trans-papillary stents are currently being performed in general clinical practices, depending&#xD;
      on the preference of the endoscopists. Until now, the comparison of the clinical results of&#xD;
      the two procedures has been scarcely studied, and there is no prospective study yet.&#xD;
      Therefore, researchers aim to compare the clinical results of two stent procedures through&#xD;
      prospective randomized controlled studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If surgical treatment is not possible in patients with malignant obstruction in the common&#xD;
      bile duct, endoscopic metal stent placement to resolve biliary obstruction is a standard&#xD;
      treatment that is commonly performed. The metal stents relieve the bile duct stenosis by&#xD;
      malignant tumors, helping to drain the bile and improving jaundice. There is no doubt that&#xD;
      the center of the metal stent is located in the central part of the biliary stricture, but&#xD;
      the location of the lower end of the metal stent is not fixed. The lower end of the metal&#xD;
      stent can be located in two main locations, either in the common bile duct above the major&#xD;
      ampulla or in the duodenum through the major ampulla. These procedures with supra- or&#xD;
      trans-papillary stents are performed in common and are determined by the operator's&#xD;
      preference.&#xD;
&#xD;
      According to several retrospective studies so far, trans-papillary metal stents were&#xD;
      effective in improving the initial biliary obstruction, but there was no difference in their&#xD;
      long-term effects. Mao et al. showed that trans-papillary metal stents increase jaundice-free&#xD;
      survival, and Shin et al. revealed the advantages of trans-papillary metal stents because&#xD;
      they had a high success rate of secondary endoscopic procedures. On the contrary, Okamoto et&#xD;
      al. showed that acute cholangitis more developed after trans-papillary metal stents&#xD;
      placement, while Joe et al. revealed the advantages of supra-papillary metal stents because&#xD;
      they reduce acute pancreatitis after the procedures. It has not yet been determined which&#xD;
      method is effective. So far studies are all retrospective, and some of them placed the metal&#xD;
      stents in a percutaneous way rather than endoscopy without sphincterotomy. Besides, some&#xD;
      studies included intra-hepatic or hilar bile duct strictures, making it difficult to&#xD;
      interpret the results.&#xD;
&#xD;
      Therefore, through a prospective randomized controlled study, the researchers want to compare&#xD;
      the clinical results of supra- and trans-papillary metal stents placed by endoscopes in&#xD;
      malignant common bile duct obstruction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 4, 2021</start_date>
  <completion_date type="Anticipated">December 12, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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>
    <intervention_model_description>supra-papillary metal stent group&#xD;
trans-papillary metal stent group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Assigned groups are secreted to the participant and outcome assessors</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stent function maintenance duration</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>jaundice free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stone or sludge occurrence</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>in-stent or above stent bile duct stone formation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in-stent stenosis or tumor overgrowth</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>stenosis due to tumor growth: in-stent or over the stent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acute cholangitis occurrence</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>after procedure acute cholangitis occurrence rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stent migration rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>spontaneous migration rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>From date of randomization until the date of date of death from any cause, assessed up to 36 months</time_frame>
    <description>duration between stent placement and death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">156</enrollment>
  <condition>Common Bile Duct Stricture</condition>
  <arm_group>
    <arm_group_label>supra-papillary metal stent group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The distal ends of metal stents are located above the major papilla in the common bile duct.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>trans-papillary metal stent group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The distal ends of metal stents are located below the major papilla in the duodenum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Metal stent placement</intervention_name>
    <description>Non-covered biliary metal stents are placed by endoscopy. The distal ends of metal stents are located above the major ampulla in the common bile duct or below the major ampulla in the duodenum.</description>
    <arm_group_label>supra-papillary metal stent group</arm_group_label>
    <arm_group_label>trans-papillary metal stent group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with common bile duct obstruction due to malignancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intrahepatic or perihilar bile duct obstruction (except Klatskin type I)&#xD;
&#xD;
          -  patients who have operability or want surgery&#xD;
&#xD;
          -  strictures located within 2 cm from the end of distal common bile duct&#xD;
&#xD;
          -  patients who are not able to undergo endoscopy due to cardiovascular or pulmonary&#xD;
             diseases&#xD;
&#xD;
          -  patients whose informed consents are not received&#xD;
&#xD;
          -  patients in whom an endoscope can not access to the ampulla due to anatomical&#xD;
             deformity by previous surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jae Hyuck Chang, Ph, Dr</last_name>
    <phone>82-32-340-7086</phone>
    <email>wwjjaang@hanmail.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jae Hyuck Chang</name>
      <address>
        <city>Bucheon-si</city>
        <state>Kyunggi</state>
        <zip>14647</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae H Chang, PhD</last_name>
      <phone>82323407086</phone>
      <email>wwjjaang@hanmail.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bucheon St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Jae Hyuck Chang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>metal stent</keyword>
  <keyword>common bile duct obstruction</keyword>
  <keyword>endoscopic retrograde cholangiopancreatography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee&#xD;
To achieve aims in the approved proposal&#xD;
Proposals may be submitted up to 36 months following article publication.</ipd_access_criteria>
  </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/NCT04503291
org study id: BucheonStMarys
nct id: NCT04503291
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
If surgical treatment is not possible in patients with malignant obstruction in the common
      bile duct, placing metal stents using endoscopy is a standardized treatment to resolve
      biliary obstruction. The metal stent is located in the bile duct to cover the stenotic
      portion by malignant tumors.

      The lower end of the metal stent can be located inside the common bile duct above the major
      ampulla or in the duodenum through the major ampulla. These two procedures with supra- or
      trans-papillary stents are currently being performed in general clinical practices, depending
      on the preference of the endoscopists. Until now, the comparison of the clinical results of
      the two procedures has been scarcely studied, and there is no prospective study yet.
      Therefore, researchers aim to compare the clinical results of two stent procedures through
      prospective randomized controlled studies.
If surgical treatment is not possible in patients with malignant obstruction in the common
      bile duct, endoscopic metal stent placement to resolve biliary obstruction is a standard
      treatment that is commonly performed. The metal stents relieve the bile duct stenosis by
      malignant tumors, helping to drain the bile and improving jaundice. There is no doubt that
      the center of the metal stent is located in the central part of the biliary stricture, but
      the location of the lower end of the metal stent is not fixed. The lower end of the metal
      stent can be located in two main locations, either in the common bile duct above the major
      ampulla or in the duodenum through the major ampulla. These procedures with supra- or
      trans-papillary stents are performed in common and are determined by the operator's
      preference.

      According to several retrospective studies so far, trans-papillary metal stents were
      effective in improving the initial biliary obstruction, but there was no difference in their
      long-term effects. Mao et al. showed that trans-papillary metal stents increase jaundice-free
      survival, and Shin et al. revealed the advantages of trans-papillary metal stents because
      they had a high success rate of secondary endoscopic procedures. On the contrary, Okamoto et
      al. showed that acute cholangitis more developed after trans-papillary metal stents
      placement, while Joe et al. revealed the advantages of supra-papillary metal stents because
      they reduce acute pancreatitis after the procedures. It has not yet been determined which
      method is effective. So far studies are all retrospective, and some of them placed the metal
      stents in a percutaneous way rather than endoscopy without sphincterotomy. Besides, some
      studies included intra-hepatic or hilar bile duct strictures, making it difficult to
      interpret the results.

      Therefore, through a prospective randomized controlled study, the researchers want to compare
      the clinical results of supra- and trans-papillary metal stents placed by endoscopes in
      malignant common bile duct obstruction.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: supra-papillary metal stent group
trans-papillary metal stent group
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Assigned groups are secreted to the participant and outcome assessors
measure: Stent function maintenance duration
time frame: through study completion, an average of 1 year
description: jaundice free survival
measure: stone or sludge occurrence
time frame: through study completion, an average of 1 year
description: in-stent or above stent bile duct stone formation
measure: in-stent stenosis or tumor overgrowth
time frame: through study completion, an average of 1 year
description: stenosis due to tumor growth: in-stent or over the stent
measure: acute cholangitis occurrence
time frame: through study completion, an average of 1 year
description: after procedure acute cholangitis occurrence rate
measure: stent migration rate
time frame: through study completion, an average of 1 year
description: spontaneous migration rate
measure: overall survival
time frame: From date of randomization until the date of date of death from any cause, assessed up to 36 months
description: duration between stent placement and death
arm group label: supra-papillary metal stent group
arm group type: Experimental
description: The distal ends of metal stents are located above the major papilla in the common bile duct.
arm group label: trans-papillary metal stent group
arm group type: Active Comparator
description: The distal ends of metal stents are located below the major papilla in the duodenum.
intervention type: Procedure
intervention name: Metal stent placement
description: Non-covered biliary metal stents are placed by endoscopy. The distal ends of metal stents are located above the major ampulla in the common bile duct or below the major ampulla in the duodenum.
arm group label: supra-papillary metal stent group
arm group label: trans-papillary metal stent group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jae Hyuck Chang, Ph, Dr
phone: 82-32-340-7086
email: wwjjaang@hanmail.net
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Bucheon St. Mary's Hospital
investigator full name: Jae Hyuck Chang
investigator title: Professor
mesh term: Constriction, Pathologic
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Immediately following publication. No end date
ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee
To achieve aims in the approved proposal
Proposals may be submitted up to 36 months following article publication.