<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/NCT03767959</url>
  </required_header>
  <id_info>
    <org_study_id>C201811</org_study_id>
    <nct_id>NCT03767959</nct_id>
  </id_info>
  <brief_title>Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy</brief_title>
  <official_title>Evaluation of Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chen Xiaoping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</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>
      To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for&#xD;
      malignant neoplasms located in the peri-ampullary region, and is increasingly being used for&#xD;
      the treatment of cancer through the resection of the premalignant precursors for invasive&#xD;
      carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications&#xD;
      associated with substantial clinical implications following PD, which significantly affects&#xD;
      mortality rate, length of hospital stay, and overall hospital costs. Therefore, the&#xD;
      prevention of POPF has always been a high priority for our group as well as other&#xD;
      international surgical groups. In 1995, investigators' group established the Chen's U-stitch&#xD;
      approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with&#xD;
      transpancreatic transverse U-sutures after PD, and the preliminary results were quite&#xD;
      encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized,&#xD;
      parallel-group controlled, clinical trial to evaluate the effect and safety of the new&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the&#xD;
      effect and safety of Chen's U-Suture technique for pancreaticojejunostomy following&#xD;
      pancreaticoduodenectomy. Investigators plan to enroll 960 patients in this study and eligible&#xD;
      patients will be randomly divided into two groups. One group will use Chen's U-Suture&#xD;
      technique and other group will use classic duct-to-mucosa technique. All patients will be&#xD;
      followed up for 3 month after surgery, and primary outcome is POPF, other outcome such as&#xD;
      duration of operation, grade of POPF, morbidity, mortality, length of hospital stay,&#xD;
      reoperation rate, postoperative pancreatic function and postoperative incidence of chronic&#xD;
      pancreatic diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 24, 2019</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pancreatic Fistula(POPF)</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>POPF will be strictly classified according to IGSPF criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of operation</measure>
    <time_frame>Intraoperative</time_frame>
    <description>The time of operation count by minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade of POPF</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>The grade of POPF will be strictly classified according to IGSPF criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>Within 90 days after surgery</time_frame>
    <description>The incidence of operative complications within 90 days after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>The death occurred within 30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay after surgery</measure>
    <time_frame>From first day after surgery to release from hospital (anticipate 5 days minimally)</time_frame>
    <description>Days between surgery and hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation rate</measure>
    <time_frame>Within one year after surgery</time_frame>
    <description>The incidence of reoperation within 1 year after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pancreatic function</measure>
    <time_frame>Within one year after surgery</time_frame>
    <description>Postoperative pancreatic function such as blood glucose, blood diastasum diastace, urine amylase, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative incidence of chronic pancreatic diseases</measure>
    <time_frame>Within one year after surgery</time_frame>
    <description>The incidence of chronic pancreatic diseases, the chronic pancreatic diseases include chronic pancreatitis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">960</enrollment>
  <condition>Pancreaticoduodenectomy</condition>
  <arm_group>
    <arm_group_label>Chen's U-Suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Classic pancreatic duct to mucosa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chen's U-Suture</intervention_name>
    <description>Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures</description>
    <arm_group_label>Chen's U-Suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Classic pancreatic duct to mucosa</intervention_name>
    <description>A Classical anastomosis technique for Pancreaticojejunostomy</description>
    <arm_group_label>Classic pancreatic duct to mucosa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 18 to 75 years of age, inclusive.&#xD;
&#xD;
          2. Patients have a diagnosis of benign and malignant diseases of the pancreatic head and&#xD;
             periampullary region and requiring pancreaticoduodenectomy.&#xD;
&#xD;
          3. Patients have not been treated with any anticancer medications and immunotherapy prior&#xD;
             to surgery&#xD;
&#xD;
          4. Patients have not been accompanied by serious physical diseases of heart, lung, brain,&#xD;
             etc., and can generally tolerable for surgery.&#xD;
&#xD;
          5. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant or breastfeeding.&#xD;
&#xD;
          2. Patients scheduled to undergo pancreatogastrostomy.&#xD;
&#xD;
          3. Patients whose pancreatic duct cannot be located.&#xD;
&#xD;
          4. Patients with history of previous pancreatic surgery, server acute or chronic disease&#xD;
             or surgical contraindication.&#xD;
&#xD;
          5. Patients with HIV-infectious or other AIDS-related disease.&#xD;
&#xD;
          6. Patients have any condition that in the judgement of the Investigators would make the&#xD;
             subject inappropriate for entry into this study.&#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>Xiaoping Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoping Chen</last_name>
    <phone>86-027-83663400</phone>
    <email>chenxp@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoping Chen</last_name>
      <email>chenxp@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Chen Xiaoping</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03767959
org study id: C201811
nct id: NCT03767959
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for
      malignant neoplasms located in the peri-ampullary region, and is increasingly being used for
      the treatment of cancer through the resection of the premalignant precursors for invasive
      carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications
      associated with substantial clinical implications following PD, which significantly affects
      mortality rate, length of hospital stay, and overall hospital costs. Therefore, the
      prevention of POPF has always been a high priority for our group as well as other
      international surgical groups. In 1995, investigators' group established the Chen's U-stitch
      approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with
      transpancreatic transverse U-sutures after PD, and the preliminary results were quite
      encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized,
      parallel-group controlled, clinical trial to evaluate the effect and safety of the new
      technique.
This is a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the
      effect and safety of Chen's U-Suture technique for pancreaticojejunostomy following
      pancreaticoduodenectomy. Investigators plan to enroll 960 patients in this study and eligible
      patients will be randomly divided into two groups. One group will use Chen's U-Suture
      technique and other group will use classic duct-to-mucosa technique. All patients will be
      followed up for 3 month after surgery, and primary outcome is POPF, other outcome such as
      duration of operation, grade of POPF, morbidity, mortality, length of hospital stay,
      reoperation rate, postoperative pancreatic function and postoperative incidence of chronic
      pancreatic diseases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative Pancreatic Fistula(POPF)
time frame: Within 30 days after surgery
description: POPF will be strictly classified according to IGSPF criteria
measure: Duration of operation
time frame: Intraoperative
description: The time of operation count by minute.
measure: Grade of POPF
time frame: Within 30 days after surgery
description: The grade of POPF will be strictly classified according to IGSPF criteria
measure: Morbidity
time frame: Within 90 days after surgery
description: The incidence of operative complications within 90 days after surgery.
measure: Mortality
time frame: Within 30 days after surgery
description: The death occurred within 30 days after surgery
measure: Length of hospital stay after surgery
time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)
description: Days between surgery and hospital discharge
measure: Reoperation rate
time frame: Within one year after surgery
description: The incidence of reoperation within 1 year after surgery.
measure: Postoperative pancreatic function
time frame: Within one year after surgery
description: Postoperative pancreatic function such as blood glucose, blood diastasum diastace, urine amylase, etc.
measure: Postoperative incidence of chronic pancreatic diseases
time frame: Within one year after surgery
description: The incidence of chronic pancreatic diseases, the chronic pancreatic diseases include chronic pancreatitis.
arm group label: Chen's U-Suture
arm group type: Experimental
description: Patients in this group will treated by Chen's U-suture technique in pancreaticojejunostomy.
arm group label: Classic pancreatic duct to mucosa
arm group type: Active Comparator
description: Patients in this group will treated by classic pancreatic duct to mucosa technique in pancreaticojejunostomy.
intervention type: Procedure
intervention name: Chen's U-Suture
description: Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures
arm group label: Chen's U-Suture
intervention type: Procedure
intervention name: Classic pancreatic duct to mucosa
description: A Classical anastomosis technique for Pancreaticojejunostomy
arm group label: Classic pancreatic duct to mucosa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiaoping Chen
role: Principal Investigator
affiliation: Tongji Hospital
last name: Xiaoping Chen
phone: 86-027-83663400
email: chenxp@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Tongji Hospital
investigator full name: Chen Xiaoping
investigator title: Principal Investigator