<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/NCT03785743</url>
  </required_header>
  <id_info>
    <org_study_id>TJDBPS07</org_study_id>
    <nct_id>NCT03785743</nct_id>
  </id_info>
  <brief_title>Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma</brief_title>
  <official_title>Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Xuzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hunan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Afﬁliated Hospital of North Sichuan Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with&#xD;
      poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally&#xD;
      invasive surgery has been progressively developed, first with the advent of&#xD;
      hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues&#xD;
      are currently being debated, including the superiority between total laparoscopic&#xD;
      pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing&#xD;
      these two surgery techniques are merging and randomized controlled trials (RCT) are lacking&#xD;
      but clearly required.&#xD;
&#xD;
      Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing&#xD;
      TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent&#xD;
      PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after&#xD;
      surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease&#xD;
      free survival (DFS) and quality of life. The duration of the entire trial is seven years&#xD;
      including prearrangement, a presumably five-year follow-up and analyses.&#xD;
&#xD;
      Discussion: Despite the fact there are several RCTs comparing minimally invasive&#xD;
      pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the&#xD;
      first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized&#xD;
      to assess whether TLPD has superiority over OPD in recovery and other aspects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2027</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>5-year overall survival</measure>
    <time_frame>5 year</time_frame>
    <description>5-year overall survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>the interval between the day of surgery and the day of death for various reasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>the interval between the day of surgery and the day of tumour recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days</time_frame>
    <description>the percentage of patients who died within 90 days postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication rate</measure>
    <time_frame>90 days</time_frame>
    <description>complications related to PD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comprehensive complication index</measure>
    <time_frame>90 days</time_frame>
    <description>calculated as the sum of all complications that are weighted for their severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of stay</measure>
    <time_frame>90 days</time_frame>
    <description>the number of nights spent in the hospital from the end of the surgical procedure until discharge or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative indicators</measure>
    <time_frame>90 days</time_frame>
    <description>description of the patients' intraoperative condition relating to the safety of patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pancreatic Carcinoma</condition>
  <condition>Laparoscopic</condition>
  <condition>Pancreaticoduodenectomy</condition>
  <arm_group>
    <arm_group_label>TLPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total laparoscopic pancreaticoduodenectomy for pancreatic cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open pancreaticoduodenectomy for pancreatic cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TLPD Surgery</intervention_name>
    <description>TLPD</description>
    <arm_group_label>TLPD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>OPD Surgery</intervention_name>
    <description>OPD</description>
    <arm_group_label>OPD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 years and 75 years.&#xD;
&#xD;
          2. Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without&#xD;
             histopathologic evidence.&#xD;
&#xD;
          3. Patients feasible to undergo both LPD and OPD according to MDT evaluations.&#xD;
&#xD;
          4. Patients understanding and willing to comply with this trial.&#xD;
&#xD;
          5. Provision of written informed consent before patient registration.&#xD;
&#xD;
          6. Patients meeting the curative treatment intent in accordance with clinical guidelines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with distant metastases, including peritoneal, liver, distant lymph node&#xD;
             metastases, and involvement of other organs.&#xD;
&#xD;
          2. Patients requiring left, central or total pancreatectomy or other palliative surgery.&#xD;
&#xD;
          3. Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.&#xD;
&#xD;
          4. History of other malignant disease.&#xD;
&#xD;
          5. Pregnant or breast-feeding women.&#xD;
&#xD;
          6. Patients with serious mental disorders.&#xD;
&#xD;
          7. Patients treated with neoadjuvant therapy.&#xD;
&#xD;
          8. Patients with vascular invasion and requiring vascular resection as evaluated by the&#xD;
             MDT team according to abdominal imaging data.&#xD;
&#xD;
          9. Body mass index &gt; 35 kg/m2.&#xD;
&#xD;
         10. Patients participating in any other clinical trials within 3 months.&#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>Renyi Qin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Renyi Qin</last_name>
    <phone>+8602783665314</phone>
    <email>172356995@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hag Zhang</last_name>
    <phone>+8602783665314</phone>
    <email>172356995@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated 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>Junfang O Zhao, MD, PhD</last_name>
      <phone>+8615827539076</phone>
      <email>zhaojunfang2012@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>February 27, 2022</last_update_submitted>
  <last_update_submitted_qc>February 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Renyi Qin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pancreatic Carcinoma</keyword>
  <keyword>Laparoscopic</keyword>
  <keyword>Pancreaticoduodenectomy</keyword>
  <keyword>Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</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/NCT03785743
org study id: TJDBPS07
nct id: NCT03785743
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
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collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with
      poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally
      invasive surgery has been progressively developed, first with the advent of
      hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues
      are currently being debated, including the superiority between total laparoscopic
      pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing
      these two surgery techniques are merging and randomized controlled trials (RCT) are lacking
      but clearly required.

      Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing
      TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent
      PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after
      surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease
      free survival (DFS) and quality of life. The duration of the entire trial is seven years
      including prearrangement, a presumably five-year follow-up and analyses.

      Discussion: Despite the fact there are several RCTs comparing minimally invasive
      pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the
      first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized
      to assess whether TLPD has superiority over OPD in recovery and other aspects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 5-year overall survival
time frame: 5 year
description: 5-year overall survival
measure: overall survival
time frame: 5 years
description: the interval between the day of surgery and the day of death for various reasons
measure: disease-free survival
time frame: 5 years
description: the interval between the day of surgery and the day of tumour recurrence
measure: 90-day mortality
time frame: 90 days
description: the percentage of patients who died within 90 days postoperatively
measure: complication rate
time frame: 90 days
description: complications related to PD
measure: comprehensive complication index
time frame: 90 days
description: calculated as the sum of all complications that are weighted for their severity
measure: length of stay
time frame: 90 days
description: the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
measure: intraoperative indicators
time frame: 90 days
description: description of the patients' intraoperative condition relating to the safety of patients
arm group label: TLPD
arm group type: Experimental
description: Total laparoscopic pancreaticoduodenectomy for pancreatic cancer
arm group label: OPD
arm group type: Experimental
description: Open pancreaticoduodenectomy for pancreatic cancer
intervention type: Procedure
intervention name: TLPD Surgery
description: TLPD
arm group label: TLPD
intervention type: Procedure
intervention name: OPD Surgery
description: OPD
arm group label: OPD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Renyi Qin
role: Principal Investigator
affiliation: Tongji Hospital
last name: Renyi Qin
phone: +8602783665314
email: 172356995@qq.com
last name: Hag Zhang
phone: +8602783665314
email: 172356995@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Renyi Qin
investigator title: Professor
mesh term: Carcinoma
mesh term: Pancreatic Neoplasms
sharing ipd: Undecided