<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/NCT03792048</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF-CRF-2015-001-2</org_study_id>
    <nct_id>NCT03792048</nct_id>
  </id_info>
  <brief_title>Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure</brief_title>
  <official_title>Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on&#xD;
      our initial experience, the investigators have successfully utilized magnetic anastomosis for&#xD;
      biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. The current study&#xD;
      was to design a prospective and case-control study with utilization of magnetic compression&#xD;
      anastomosis for pancreaticojejunostomy and biliojejunostomy in Whipple's procedure versus&#xD;
      traditional hand-sewn technique on the postoperative morbidity, such as biliary/pancreatic&#xD;
      fistula, hemorrhage, anastomotic stenosis, etc. In addition, the investigators are seeking to&#xD;
      assess the safety and formation of the anastomosis by magnetic technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr&#xD;
      nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or&#xD;
      pancreatic drainage before formation of anastomoses. The outside diameter (OD) of the magnets&#xD;
      ranges from 5mm to 15mm. In fact, for biliojejunostomy, larger magnets are applied, whereas&#xD;
      for pancreaticojejunostomy, smaller magnets are routinely used. This study is a&#xD;
      single-center, parallel controlled trial to evaluate the safety and effectiveness of magnetic&#xD;
      compression technique for biliojejunostomy and pancreaticojejunostomy, versus traditional&#xD;
      hand-sewn techniques on the postoperative morbidity of the patients. And also how to avoid&#xD;
      mutual attraction of the two pairs of magnets, formation of bilio-/pancreaticojejunostomy&#xD;
      time, discharge rule of the magnets will be all evaluated in the current study.&#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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of anastomotic fistula</measure>
    <time_frame>1 month post operation</time_frame>
    <description>Incidence of biliary or pancreatic fistula after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of bilio-/pancreaticojejunostomy time</measure>
    <time_frame>during operation</time_frame>
    <description>Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average length of postoperative hospital stay</measure>
    <time_frame>1 to 4 weeks postoperation</time_frame>
    <description>length of hospital stay (days) after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization cost</measure>
    <time_frame>1 to 4 weeks postoperation</time_frame>
    <description>cost in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of biliojejunostomic stricture</measure>
    <time_frame>12 months post operation</time_frame>
    <description>Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of pancreaticojejunostomic stricture</measure>
    <time_frame>12 months post operation</time_frame>
    <description>Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cholangiocarcinoma</condition>
  <condition>Pancreatic Neoplasms</condition>
  <condition>Duodenal Neoplasms</condition>
  <condition>Pancreatolithiasis</condition>
  <condition>Chronic Pancreatitis</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 and pancreaticojejunostomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Anastomosis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Compressive Anastomosis</intervention_name>
    <description>A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy</description>
    <arm_group_label>Magnetic Compressive 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 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 biliary 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 weeks&#xD;
        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>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi Lv, MD,PHD</last_name>
    <phone>0086-13991200581</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>First Affiliated Hospital of Xian JiaotongUniversity</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>Zhe Feng, MD</last_name>
      <phone>0086-17749083602</phone>
      <email>624779797@qq.com</email>
    </contact_backup>
  </location>
  <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>Xu-Feng Zhang, MD, PhD</last_name>
      <phone>86 29 85323900</phone>
      <email>xfzhang125@126.com</email>
    </contact>
  </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>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</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>pancreaticojejunostomy</keyword>
  <keyword>Magnetic Compressive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Duodenal Neoplasms</mesh_term>
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</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/NCT03792048
org study id: XJTU1AF-CRF-2015-001-2
nct id: NCT03792048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on
      our initial experience, the investigators have successfully utilized magnetic anastomosis for
      biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. The current study
      was to design a prospective and case-control study with utilization of magnetic compression
      anastomosis for pancreaticojejunostomy and biliojejunostomy in Whipple's procedure versus
      traditional hand-sewn technique on the postoperative morbidity, such as biliary/pancreatic
      fistula, hemorrhage, anastomotic stenosis, etc. In addition, the investigators are seeking to
      assess the safety and formation of the anastomosis by magnetic technique.
The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr
      nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or
      pancreatic drainage before formation of anastomoses. The outside diameter (OD) of the magnets
      ranges from 5mm to 15mm. In fact, for biliojejunostomy, larger magnets are applied, whereas
      for pancreaticojejunostomy, smaller magnets are routinely used. This study is a
      single-center, parallel controlled trial to evaluate the safety and effectiveness of magnetic
      compression technique for biliojejunostomy and pancreaticojejunostomy, versus traditional
      hand-sewn techniques on the postoperative morbidity of the patients. And also how to avoid
      mutual attraction of the two pairs of magnets, formation of bilio-/pancreaticojejunostomy
      time, discharge rule of the magnets will be all evaluated in the current study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of anastomotic fistula
time frame: 1 month post operation
description: Incidence of biliary or pancreatic fistula after surgery
measure: Length of bilio-/pancreaticojejunostomy time
time frame: during operation
description: Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy
measure: average length of postoperative hospital stay
time frame: 1 to 4 weeks postoperation
description: length of hospital stay (days) after surgery
measure: Hospitalization cost
time frame: 1 to 4 weeks postoperation
description: cost in hospital
measure: incidence of biliojejunostomic stricture
time frame: 12 months post operation
description: Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
measure: Incidence of pancreaticojejunostomic stricture
time frame: 12 months post operation
description: Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up
arm group label: Magnetic Compressive Anastomosis
arm group type: Experimental
description: A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
arm group label: Manual Anastomosis
arm group type: No Intervention
description: Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy
intervention type: Procedure
intervention name: Magnetic Compressive Anastomosis
description: A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
arm group label: Magnetic Compressive 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: First Affiliated Hospital Xi'an Jiaotong University
last name: Yi Lv, MD,PHD
phone: 0086-13991200581
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: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Cholangiocarcinoma
mesh term: Pancreatic Neoplasms
mesh term: Duodenal Neoplasms
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
sharing ipd: Undecided