<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/NCT01695447</url>
  </required_header>
  <id_info>
    <org_study_id>ZEH-LL-CX-004-02</org_study_id>
    <nct_id>NCT01695447</nct_id>
  </id_info>
  <brief_title>Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy</brief_title>
  <official_title>Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TingBo Liang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether duct-to-mucosa is better than invagination&#xD;
      in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized&#xD;
      controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The&#xD;
      duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100&#xD;
      or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar&#xD;
      carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy&#xD;
      will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity,&#xD;
      reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better&#xD;
      than invagination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pancreatic fistula</measure>
    <time_frame>From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days</time_frame>
    <description>The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days</time_frame>
    <description>30-day or in-hospital mortality: death from any cause within 30 days after operation or any in-hospital death are considered concerned with the type of pancreaticojejunostomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days</time_frame>
    <description>any complications after operation will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation</measure>
    <time_frame>From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days</time_frame>
    <description>Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days</time_frame>
    <description>Post-operation hospital stay is assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <condition>Biliary Tract Neoplasms</condition>
  <arm_group>
    <arm_group_label>duct-to-mucosa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>invagination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>duct-to-mucosa</intervention_name>
    <arm_group_label>duct-to-mucosa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>invagination</intervention_name>
    <arm_group_label>invagination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Internal stent</intervention_name>
    <description>Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.</description>
    <arm_group_label>duct-to-mucosa</arm_group_label>
    <arm_group_label>invagination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with pancreatic cancer or other diseases which need&#xD;
             pancreaticoduodenectomy and pancreaticojejunostomy&#xD;
&#xD;
          -  18 to 80 y/o&#xD;
&#xD;
          -  Operation-tolerated&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of gastrointestinal operation&#xD;
&#xD;
          -  Pancreaticoduodenectomy is given up during operation&#xD;
&#xD;
          -  Pancreatic duct is difficult to locate&#xD;
&#xD;
          -  Patients require to exit from the study anytime&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xue-Li Bai, Ph.D.</last_name>
    <phone>+86 571 87783510</phone>
    <email>shirleybai57@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ting-Bo Liang, Ph.D., M.D.</last_name>
      <phone>+86 571 87783510</phone>
      <email>liangtingbo@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>TingBo Liang</investigator_full_name>
    <investigator_title>The Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Biliary Tract Neoplasms</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/NCT01695447
org study id: ZEH-LL-CX-004-02
nct id: NCT01695447
lead sponsor: 
The purpose of this study is to determine whether duct-to-mucosa is better than invagination
      in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized
      controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The
      duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100
      or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar
      carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy
      will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity,
      reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better
      than invagination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: pancreatic fistula
time frame: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
description: The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
measure: Mortality
time frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
description: 30-day or in-hospital mortality: death from any cause within 30 days after operation or any in-hospital death are considered concerned with the type of pancreaticojejunostomy
measure: Morbidity
time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
description: any complications after operation will be recorded.
measure: Reoperation
time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
description: Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.
measure: Hospital stay
time frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
description: Post-operation hospital stay is assessed.
arm group label: duct-to-mucosa
arm group type: Experimental
description: duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
arm group label: invagination
arm group type: Active Comparator
description: invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
intervention type: Procedure
intervention name: duct-to-mucosa
arm group label: duct-to-mucosa
intervention type: Procedure
intervention name: invagination
arm group label: invagination
intervention type: Device
intervention name: Internal stent
description: Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
arm group label: duct-to-mucosa
arm group label: invagination
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xue-Li Bai, Ph.D.
phone: +86 571 87783510
email: shirleybai57@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Zhejiang University
investigator full name: TingBo Liang
investigator title: The Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
mesh term: Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Biliary Tract Neoplasms