<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/NCT03774589</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF-CRF-2015-001-1</org_study_id>
    <nct_id>NCT03774589</nct_id>
  </id_info>
  <brief_title>Bilioenteric Anastomosis by Magnetic Compressive Technique</brief_title>
  <acronym>BAMCT</acronym>
  <official_title>Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Science Center of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwest Institute for Non-ferrous Metal Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</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 determine whether the magnetic compressive anastomosis has a&#xD;
      better outcomes than traditional manual anastomosis on bilioenteric anastomosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The bilioenteric anastomosis is one of the most common and difficult operations in&#xD;
      Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main&#xD;
      prognosis factors because of the length of suture time, the difficulty of operation, the high&#xD;
      incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize&#xD;
      the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage&#xD;
      and stricture. Currently, the majority of studies of magnetic compressive bilioenteric&#xD;
      anastomosis are merely confined within clinical case report and single-center, small sample,&#xD;
      retrospective study. This study is a prospective, randomized controlled trial. To evaluate&#xD;
      the security, reliability and convince of magnetic compressive bilioenteric anastomosis&#xD;
      versus traditional suture method on incidence of anastomotic leakage and stricture between&#xD;
      magnetic compressive anastomosis and traditional manual anastomosis among patients who need&#xD;
      bilioenteric anastomosis operation. The study is to enroll about 200 patients and divide into&#xD;
      Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B:&#xD;
      traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The&#xD;
      incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time,&#xD;
      value of serum bilirubin, length of discharge time of magnetic device and mean time of&#xD;
      hospital stay will be evaluated. The patients will drop out of the study if adverse events&#xD;
      happen, active request for dropping out, new-onset severe disease or death. The primary and&#xD;
      secondary end point will be observed by regular follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bilioenteric anastomotic leakage</measure>
    <time_frame>1 month post operation</time_frame>
    <description>To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of bilioenteric anastomosis time</measure>
    <time_frame>during operation</time_frame>
    <description>To compare the anastomotic time between magnetic and hand-sewn groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from the date of operation to expel of the magnets.</measure>
    <time_frame>1 to 4 weeks postoperation</time_frame>
    <description>To confirm the safe discharge of the magnets</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average length of postoperative hospital stay</measure>
    <time_frame>3 months</time_frame>
    <description>To compare the length of stay between magnetic and hand-sewn groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilioenteric anastomotic stricture</measure>
    <time_frame>1,3,6,12-month post operation</time_frame>
    <description>To compare the long-term outcome between magnetic and hand-sewn groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Bile Duct Injury</condition>
  <condition>Choledochal Cyst</condition>
  <condition>Biliary Calculi</condition>
  <arm_group>
    <arm_group_label>Magnetic Compressive Anastomosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A magnetic device will be used during bilioenteric anastomosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Manual Anastomosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A handsewn technique will be used during bilioenteric anastomosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Compressive Anastomosis</intervention_name>
    <description>The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.</description>
    <arm_group_label>Magnetic Compressive Anastomosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Manual Anastomosis</intervention_name>
    <description>A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.</description>
    <arm_group_label>Traditional Manual Anastomosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with age between 18 to 75&#xD;
&#xD;
          -  Patients' gender was not limited&#xD;
&#xD;
          -  Patients who were well-diagnosed and had the indication for bilioenteric anastomosis.&#xD;
&#xD;
          -  Patients whose lifetimes will be longer than 12 months.&#xD;
&#xD;
          -  Patients who are willing to join this clinical trial and informed consent form&#xD;
             voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Woman during pregnancy or lactation or anyone with mental disorder&#xD;
&#xD;
          -  The wall of hepatic duct or jejunum was too thick so that the attractive force of&#xD;
             magnetic device cannot meet the requirements of compression.&#xD;
&#xD;
          -  Any anatomical variation in bile ducts system or the inner diameter is too small so&#xD;
             that the magnetic device cannot place in.&#xD;
&#xD;
          -  Any foreign body has been implanted in body, such as heart pacemaker.&#xD;
&#xD;
          -  Surgical contraindication, including:&#xD;
&#xD;
        Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or&#xD;
        other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was&#xD;
        diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or&#xD;
        septic shock. End stage disease, complicated with biliary cirrhosis or portal&#xD;
        hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte&#xD;
        disturbance or coagulation defects; Patients have the tendency or history of bleeding.&#xD;
&#xD;
        • Any other disease in perioperation periods which needs MRI examination in the next 8&#xD;
        weeks post operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Lv, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi Lv, MD,PHD</last_name>
    <phone>86-29-85323900</phone>
    <email>luyi169@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xu-Feng Zhang, MD, PhD</last_name>
    <phone>86-29-85323626</phone>
    <email>xfzhang125@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Lv, MD，PHD</last_name>
      <phone>0086-13991200581</phone>
      <email>luyi169@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Rongfeng Wang, MD</last_name>
      <phone>0086-15877553630</phone>
      <email>15877553630@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bilioenteric anastomosis</keyword>
  <keyword>magnetic compressive technique</keyword>
  <keyword>morbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Choledochal Cyst</mesh_term>
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03774589
org study id: XJTU1AF-CRF-2015-001-1
nct id: NCT03774589
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether the magnetic compressive anastomosis has a
      better outcomes than traditional manual anastomosis on bilioenteric anastomosis.
The bilioenteric anastomosis is one of the most common and difficult operations in
      Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main
      prognosis factors because of the length of suture time, the difficulty of operation, the high
      incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize
      the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage
      and stricture. Currently, the majority of studies of magnetic compressive bilioenteric
      anastomosis are merely confined within clinical case report and single-center, small sample,
      retrospective study. This study is a prospective, randomized controlled trial. To evaluate
      the security, reliability and convince of magnetic compressive bilioenteric anastomosis
      versus traditional suture method on incidence of anastomotic leakage and stricture between
      magnetic compressive anastomosis and traditional manual anastomosis among patients who need
      bilioenteric anastomosis operation. The study is to enroll about 200 patients and divide into
      Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B:
      traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The
      incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time,
      value of serum bilirubin, length of discharge time of magnetic device and mean time of
      hospital stay will be evaluated. The patients will drop out of the study if adverse events
      happen, active request for dropping out, new-onset severe disease or death. The primary and
      secondary end point will be observed by regular follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Bilioenteric anastomotic leakage
time frame: 1 month post operation
description: To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis
measure: Length of bilioenteric anastomosis time
time frame: during operation
description: To compare the anastomotic time between magnetic and hand-sewn groups
measure: Time from the date of operation to expel of the magnets.
time frame: 1 to 4 weeks postoperation
description: To confirm the safe discharge of the magnets
measure: average length of postoperative hospital stay
time frame: 3 months
description: To compare the length of stay between magnetic and hand-sewn groups
measure: Bilioenteric anastomotic stricture
time frame: 1,3,6,12-month post operation
description: To compare the long-term outcome between magnetic and hand-sewn groups
arm group label: Magnetic Compressive Anastomosis
arm group type: Experimental
description: A magnetic device will be used during bilioenteric anastomosis.
arm group label: Traditional Manual Anastomosis
arm group type: Active Comparator
description: A handsewn technique will be used during bilioenteric anastomosis.
intervention type: Procedure
intervention name: Magnetic Compressive Anastomosis
description: The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.
arm group label: Magnetic Compressive Anastomosis
intervention type: Procedure
intervention name: Manual Anastomosis
description: A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
arm group label: Traditional Manual Anastomosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yi Lv, MD,PHD
role: Principal Investigator
affiliation: China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity
last name: Yi Lv, MD,PHD
phone: 86-29-85323900
email: luyi169@126.com
last name: Xu-Feng Zhang, MD, PhD
phone: 86-29-85323626
email: xfzhang125@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Choledochal Cyst
mesh term: Gallstones
mesh term: Calculi
sharing ipd: Undecided