<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/NCT03780946</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF-CRF-2015-001-3</org_study_id>
    <nct_id>NCT03780946</nct_id>
  </id_info>
  <brief_title>Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis</brief_title>
  <acronym>MCTPIA</acronym>
  <official_title>Magnetic Compressive Technique for Pancreatic Intestinal Anastomosis</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>Yes</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>
      In recent five years, the investigators have successfully developed different types of&#xD;
      magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and&#xD;
      pancreaticojejunostomy during Whipple. This study is designed as a prospective study by&#xD;
      utilization of the bar-like magnets for pancreaticojejunostomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Magnetic anastomosis has been attempted in continuous connection between bowel and bowel,&#xD;
      vessels and vessels, biliary and gastrointestinal tracts, as well as in recanalization of the&#xD;
      biliary stricture, and bilioenteric anastomotic stricture. During the past 15 years, the&#xD;
      investigators have designed different types of magnets, and attempted these magnets in&#xD;
      vascular, intestine, and biliary anastomosis in preclinical studies. In recent five years, we&#xD;
      have successfully developed different types of magnets and utilized in biliojejunostomy,&#xD;
      concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is&#xD;
      designed as a prospective study by utilization of the bar-like magnets for&#xD;
      pancreaticojejunostomy.&#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>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Pancreatic fistula</measure>
    <time_frame>From date of surgery to one month postoperatively</time_frame>
    <description>Leakage of pancreatic fistula, which is defined according to Clinically relevant Pancreatic fistula (PF) was defined by the International Study Group of Pancreatic Surgery in 2016: a drain output of any measurable volume of fluid with an amylase level &gt;3 times the upper limit of institutional normal serum amylase activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anastomotic stricture</measure>
    <time_frame>one year from the date of surgery</time_frame>
    <description>Anastomotic stricture, which will be verified by imaging studies or endoscopic investigations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge of the magnets</measure>
    <time_frame>3 months from the date of surgery</time_frame>
    <description>X-ray plain film is performed regularly to check the movement and discharge of the magnets</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <condition>Pancreatitis, Chronic</condition>
  <arm_group>
    <arm_group_label>Magnetic group</arm_group_label>
    <description>Magnetic anastomosis for pancreaticojejunostomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Traditional hand-sewn for pancreaticojejunostomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic anastomosis for pancreaticojejunostomy</intervention_name>
    <description>Magnetic anastomosis for pancreaticojejunostomy</description>
    <arm_group_label>Magnetic group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional hand-sewn anastomosis</intervention_name>
    <description>Traditional manual anastomosis for pancreaticojejunostomy</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patients with pancreatic neoplasm who needs pancreatic head resection, or central&#xD;
             pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy.&#xD;
&#xD;
          2. Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs&#xD;
             Frey's procedure.&#xD;
&#xD;
          3. Patients with pancreatic injury who needs pancreatic head resection, or central&#xD;
             pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy.&#xD;
&#xD;
          4. Patients who are willing to join this clinical trial and informed consent form&#xD;
             voluntarily.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pancreatic neoplasm who needs pancreatic head resection, or central&#xD;
             pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy&#xD;
&#xD;
          -  Patients with dilated pancreatic duct secondary to chronic pancreatitis who needs&#xD;
             Frey's procedure&#xD;
&#xD;
          -  Patients with pancreatic injury who needs pancreatic head resection, or central&#xD;
             pancreatectomy or partial pancreatectomy, and then pancreaticojejunostomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Woman during pregnancy or lactation or anyone with mental disorder&#xD;
&#xD;
          -  The wall of pancreatic incision is too thick so that the attractive force of magnetic&#xD;
             device cannot meet the requirements of compression&#xD;
&#xD;
          -  Any foreign body has been implanted in body, such as heart pacemaker.&#xD;
&#xD;
          -  Surgical contraindication, including Child-Pugh C with hepatic encephalopathy, and&#xD;
             anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot&#xD;
             tolerate surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>Lv Yi, 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>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>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>November 10, 2019</last_update_submitted>
  <last_update_submitted_qc>November 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>magnamosis; magnetic anastomosis; pancreaticojejunostomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03780946
org study id: XJTU1AF-CRF-2015-001-3
nct id: NCT03780946
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In recent five years, the investigators have successfully developed different types of
      magnets and utilized in biliojejunostomy, concomitant biliojejunostomy and
      pancreaticojejunostomy during Whipple. This study is designed as a prospective study by
      utilization of the bar-like magnets for pancreaticojejunostomy.
Magnetic anastomosis has been attempted in continuous connection between bowel and bowel,
      vessels and vessels, biliary and gastrointestinal tracts, as well as in recanalization of the
      biliary stricture, and bilioenteric anastomotic stricture. During the past 15 years, the
      investigators have designed different types of magnets, and attempted these magnets in
      vascular, intestine, and biliary anastomosis in preclinical studies. In recent five years, we
      have successfully developed different types of magnets and utilized in biliojejunostomy,
      concomitant biliojejunostomy and pancreaticojejunostomy during Whipple. This study is
      designed as a prospective study by utilization of the bar-like magnets for
      pancreaticojejunostomy.
observational model: Case-Control
time perspective: Prospective
measure: Pancreatic fistula
time frame: From date of surgery to one month postoperatively
description: Leakage of pancreatic fistula, which is defined according to Clinically relevant Pancreatic fistula (PF) was defined by the International Study Group of Pancreatic Surgery in 2016: a drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity.
measure: Anastomotic stricture
time frame: one year from the date of surgery
description: Anastomotic stricture, which will be verified by imaging studies or endoscopic investigations
measure: Discharge of the magnets
time frame: 3 months from the date of surgery
description: X-ray plain film is performed regularly to check the movement and discharge of the magnets
arm group label: Magnetic group
description: Magnetic anastomosis for pancreaticojejunostomy
arm group label: Control group
description: Traditional hand-sewn for pancreaticojejunostomy
intervention type: Procedure
intervention name: Magnetic anastomosis for pancreaticojejunostomy
description: Magnetic anastomosis for pancreaticojejunostomy
arm group label: Magnetic group
intervention type: Procedure
intervention name: Traditional hand-sewn anastomosis
description: Traditional manual anastomosis for pancreaticojejunostomy
arm group label: Control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yi Lv, MD, PhD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
last name: Lv Yi, 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: 
country: China
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic