<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/NCT03752086</url>
  </required_header>
  <id_info>
    <org_study_id>TJDBPS06</org_study_id>
    <nct_id>NCT03752086</nct_id>
  </id_info>
  <brief_title>Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy</brief_title>
  <official_title>Intra-operative Greater Omentum Binding to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</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>
      Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or&#xD;
      malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic&#xD;
      fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers.&#xD;
      Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic&#xD;
      surgery. Our group has proposed greater omentum binding as a novel approach to secure&#xD;
      pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary&#xD;
      data which demonstrated greater omentum binding of pancreatic stump significantly reduced the&#xD;
      occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety&#xD;
      and effectiveness of this novel approach in a large prospective randomized cohort.&#xD;
&#xD;
      Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial&#xD;
      in a single high-volume pancreatic center. A total of 200 patients who will receive DP and&#xD;
      fulfill the inclusion criteria will be randomly allocated to the greater omentum binding&#xD;
      group or the group without this step in an enhanced recovery after surgery (ERAS) setting.&#xD;
      The trial hypothesize that greater omentum binding of pancreatic stump could safely and&#xD;
      effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF.&#xD;
      The primary outcome is PF within 90 days after DP. The secondary outcomes are overall&#xD;
      morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following&#xD;
      DP. The duration of entire trial is presumably three years, including prearrangement,&#xD;
      two-year inclusion period, and data analysis.&#xD;
&#xD;
      Discussion: The current trial will be the first in demonstrating safety and effectiveness of&#xD;
      greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic&#xD;
      center. This approach will offer an inexpensive, technically easy, and secure coverage&#xD;
      technique for the pancreatic stump in DP and may be particularly useful for patients with a&#xD;
      soft pancreas which is a markedly risk factor of PF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">January 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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pancreatic fistula</measure>
    <time_frame>90 days</time_frame>
    <description>Incidence of pancreatic fistula defined by ISGPF classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall morbidity</measure>
    <time_frame>90 days</time_frame>
    <description>Incidence of any type of postoperative morbidity after distal pancreatectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Incidence of patients deceased after distal pancreatectomy within follow-up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major complications (Clavien-Dindo ≥III)</measure>
    <time_frame>90 days</time_frame>
    <description>Incidence of major complications defined as a complication with Clavien-Dindo score ≥III</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pancreatic Fistula</condition>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Greater omentum binding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bind greater omentum to pancreatic stump after distal pancreatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancreatic stump exposed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pancreatic stump exposed without binding greater omentum after distal pancreatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>greater omentum binding</intervention_name>
    <description>Bind pancreatic stump using greater omentum after distal pancreatectomy</description>
    <arm_group_label>Greater omentum binding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pancreatic stump exposed without omentum binding</intervention_name>
    <description>Pancreatic stump exposed without greater omentum binding after distal pancreatectomy</description>
    <arm_group_label>Pancreatic stump exposed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who undergo DP whether made by open or laparoscopic surgery;&#xD;
&#xD;
          -  Patients age 18 to 75 years;&#xD;
&#xD;
          -  Patients benefit from distal pancreatectomy according to NCCN guidelines;&#xD;
&#xD;
          -  The subject understands the nature of this trial and willing to comply, and ability to&#xD;
             provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node&#xD;
             metastases, involvement of other organs;&#xD;
&#xD;
          -  History of abdominal disease or surgery which may results in obvious omentum adhesion;&#xD;
&#xD;
          -  Synchronous malignancy in other organs;&#xD;
&#xD;
          -  Patients with high operative risk as defined by the American Society of&#xD;
             Anesthesiologists (ASA) score &gt;4;&#xD;
&#xD;
          -  Pregnant women.&#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, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Biliary and Pancreatic Surgery, Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Junfang Zhao</last_name>
    <phone>+8615827539076</phone>
    <email>zhaojunfang2012@hotmail.com</email>
  </overall_contact>
  <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>
    <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>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</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, Chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Pancreatic Fistula</mesh_term>
    <mesh_term>Fistula</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/NCT03752086
org study id: TJDBPS06
nct id: NCT03752086
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or
      malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic
      fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers.
      Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic
      surgery. Our group has proposed greater omentum binding as a novel approach to secure
      pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary
      data which demonstrated greater omentum binding of pancreatic stump significantly reduced the
      occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety
      and effectiveness of this novel approach in a large prospective randomized cohort.

      Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial
      in a single high-volume pancreatic center. A total of 200 patients who will receive DP and
      fulfill the inclusion criteria will be randomly allocated to the greater omentum binding
      group or the group without this step in an enhanced recovery after surgery (ERAS) setting.
      The trial hypothesize that greater omentum binding of pancreatic stump could safely and
      effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF.
      The primary outcome is PF within 90 days after DP. The secondary outcomes are overall
      morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following
      DP. The duration of entire trial is presumably three years, including prearrangement,
      two-year inclusion period, and data analysis.

      Discussion: The current trial will be the first in demonstrating safety and effectiveness of
      greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic
      center. This approach will offer an inexpensive, technically easy, and secure coverage
      technique for the pancreatic stump in DP and may be particularly useful for patients with a
      soft pancreas which is a markedly risk factor of PF.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: pancreatic fistula
time frame: 90 days
description: Incidence of pancreatic fistula defined by ISGPF classification
measure: overall morbidity
time frame: 90 days
description: Incidence of any type of postoperative morbidity after distal pancreatectomy
measure: mortality
time frame: 90 days
description: Incidence of patients deceased after distal pancreatectomy within follow-up period
measure: major complications (Clavien-Dindo ≥III)
time frame: 90 days
description: Incidence of major complications defined as a complication with Clavien-Dindo score ≥III
arm group label: Greater omentum binding
arm group type: Experimental
description: Bind greater omentum to pancreatic stump after distal pancreatectomy
arm group label: Pancreatic stump exposed
arm group type: Experimental
description: pancreatic stump exposed without binding greater omentum after distal pancreatectomy
intervention type: Procedure
intervention name: greater omentum binding
description: Bind pancreatic stump using greater omentum after distal pancreatectomy
arm group label: Greater omentum binding
intervention type: Procedure
intervention name: Pancreatic stump exposed without omentum binding
description: Pancreatic stump exposed without greater omentum binding after distal pancreatectomy
arm group label: Pancreatic stump exposed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Renyi Qin, MD, PhD
role: Principal Investigator
affiliation: Department of Biliary and Pancreatic Surgery, Tongji Hospital
last name: Junfang Zhao
phone: +8615827539076
email: zhaojunfang2012@hotmail.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Renyi Qin
investigator title: Professor, Chief physician
mesh term: Pancreatic Neoplasms
mesh term: Pancreatic Fistula
mesh term: Fistula
sharing ipd: Undecided