xml: <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/NCT05965466</url>
    </required_header>
    <id_info>
      <org_study_id>GGBS</org_study_id>
      <nct_id>NCT05965466</nct_id>
    </id_info>
    <brief_title>The Incidence of Gallstones After Gastrectomy</brief_title>
    <official_title>Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hepatopancreatobiliary Surgery Institute of Gansu Province</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hepatopancreatobiliary Surgery Institute of Gansu Province</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 provide preventive and therapeutic strategies for participants with gallstones after&#xD;
        gastric cancer by comparing the risk of postoperative gallbladder stone formation with two&#xD;
        different resection ranges using the Roux-en-Y reconstruction modality in radical gastric&#xD;
        cancer surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A large number of clinical studies have found that the incidence of gallstones in patients&#xD;
        after radical gastric cancer surgery is higher than that in the normal population. However,&#xD;
        the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in&#xD;
        patients with gastric cancer remains controversial. A previous study found a statistically&#xD;
        significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal&#xD;
        gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected&#xD;
        cohort study to collect further participants with gastric cancer who underwent total&#xD;
        gastrectomy to answer whether different surgical resection ranges during surgery increase the&#xD;
        incidence of gallstones this question.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Distal gastrectomy and Total gastrectomy</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of gallstone patients</measure>
      <time_frame>5years</time_frame>
      <description>Two groups of patients with gastric cancer had a follow-up for more than one year and the number of patients with gallbladder stones on B-ultrasound or Computed Tomography (CT)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients with postoperative complications</measure>
      <time_frame>5years</time_frame>
      <description>The number of patients with postoperative complications such as abdominal haemorrhage, fistula, nausea, vomiting, abdominal infection and incision infection in 2 groups of gastric cancer patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with bile duct stones</measure>
      <time_frame>5years</time_frame>
      <description>Two groups of patients with gastric cancer had a follow-up for more than one year. Clinical signs such as Charcot's triad and ultrasound, Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) show the number of patients with bile duct stones</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">504</enrollment>
    <condition>Gallstone</condition>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>Distal gastrectomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Distal subtotal gastrectomy was performed after exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by residual gastrojejunal Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Total gastrectomy</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Total gastrectomy was performed after the exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by oesophageal jejunum Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Distal gastrectomy and radical resection</intervention_name>
      <description>Distal gastrectomy and Roux-en-Y anastomosis</description>
      <arm_group_label>Distal gastrectomy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Total gastrectomy and radical resection</intervention_name>
      <description>Total gastrectomy and Roux-en-Y anastomosis</description>
      <arm_group_label>Total gastrectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with Gastric Cancer underwent Gastrectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 18 years or age greater than 75 years;&#xD;
  &#xD;
            -  Not Roux-en-Y reconstruction;&#xD;
  &#xD;
            -  R0 excision is not achieved;&#xD;
  &#xD;
            -  Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;&#xD;
  &#xD;
            -  Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic&#xD;
               cholecystitis;&#xD;
  &#xD;
            -  Preoperative neoadjuvant chemotherapy or radiotherapy;&#xD;
  &#xD;
            -  Previous history of malignant tumours;&#xD;
  &#xD;
            -  Patients with mental or developmental abnormalities or women during pregnancy or&#xD;
               breastfeeding;&#xD;
  &#xD;
            -  Gastric perforation or bleeding leading to emergency surgery;&#xD;
  &#xD;
            -  Palliative surgical treatment;&#xD;
  &#xD;
            -  Incomplete case information.&#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>Wenbo Meng, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hepatopancreatobiliary Surgery Institute of Gansu Province</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wenbo Meng, M.D.</last_name>
      <phone>13919177177</phone>
      <email>mengwb@lzu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Baoping Zhang, M.D.</last_name>
      <phone>+8613893454820</phone>
      <email>zhangbp21@lzu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hepatopancreatobiliary Surgery Institute of Gansu Province</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <zip>730000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenbo Meng, MD,PhD</last_name>
        <phone>+8613919177177</phone>
        <email>mengwb@lzu.edu.cn</email>
      </contact>
      <investigator>
        <last_name>Wenbo Meng, MD,PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Wuwei Tumor Hospital</name>
        <address>
          <city>Wuwei</city>
          <state>Gansu</state>
          <zip>733099</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peng Nie, M.D.</last_name>
        <phone>+8615294333003</phone>
        <email>nie.peng2008@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24.</citation>
      <PMID>27433395</PMID>
    </results_reference>
    <results_reference>
      <citation>Wu CH, Huang KH, Chen MH, Fang WL, Chao Y, Lo SS, Li AF, Wu CW, Shyr YM. Comparison of the Long-term Outcome Between Billroth-I and Roux-en-Y Reconstruction Following Distal Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2021 Aug;25(8):1955-1961. doi: 10.1007/s11605-020-04867-1. Epub 2020 Nov 17.</citation>
      <PMID>33205309</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hepatopancreatobiliary Surgery Institute of Gansu Province</investigator_affiliation>
      <investigator_full_name>Wenbo Meng</investigator_full_name>
      <investigator_title>Director of Surgery</investigator_title>
    </responsible_party>
    <keyword>Gallstone</keyword>
    <keyword>Gastric Cancer</keyword>
    <keyword>Gastrectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Gallstones</mesh_term>
      <mesh_term>Cholelithiasis</mesh_term>
      <mesh_term>Cholecystolithiasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965466
  org study id: GGBS
  nct id: NCT05965466
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To provide preventive and therapeutic strategies for participants with gallstones after
        gastric cancer by comparing the risk of postoperative gallbladder stone formation with two
        different resection ranges using the Roux-en-Y reconstruction modality in radical gastric
        cancer surgery.
  A large number of clinical studies have found that the incidence of gallstones in patients
        after radical gastric cancer surgery is higher than that in the normal population. However,
        the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in
        patients with gastric cancer remains controversial. A previous study found a statistically
        significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal
        gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected
        cohort study to collect further participants with gastric cancer who underwent total
        gastrectomy to answer whether different surgical resection ranges during surgery increase the
        incidence of gallstones this question.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Distal gastrectomy and Total gastrectomy
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of gallstone patients
  time frame: 5years
  description: Two groups of patients with gastric cancer had a follow-up for more than one year and the number of patients with gallbladder stones on B-ultrasound or Computed Tomography (CT)
  measure: Number of patients with postoperative complications
  time frame: 5years
  description: The number of patients with postoperative complications such as abdominal haemorrhage, fistula, nausea, vomiting, abdominal infection and incision infection in 2 groups of gastric cancer patients
  measure: Number of patients with bile duct stones
  time frame: 5years
  description: Two groups of patients with gastric cancer had a follow-up for more than one year. Clinical signs such as Charcot's triad and ultrasound, Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) show the number of patients with bile duct stones
  arm group label: Distal gastrectomy
  arm group type: Experimental
  description: Distal subtotal gastrectomy was performed after exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by residual gastrojejunal Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.
  arm group label: Total gastrectomy
  arm group type: Sham Comparator
  description: Total gastrectomy was performed after the exclusion of contraindications to surgery. Gastrointestinal reconstruction was performed by oesophageal jejunum Roux-en-Y anastomosis. Anastomosis was performed ex vivo or in vivo.
  intervention type: Procedure
  intervention name: Distal gastrectomy and radical resection
  description: Distal gastrectomy and Roux-en-Y anastomosis
  arm group label: Distal gastrectomy
  intervention type: Procedure
  intervention name: Total gastrectomy and radical resection
  description: Total gastrectomy and Roux-en-Y anastomosis
  arm group label: Total gastrectomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Wenbo Meng, M.D.
  role: Principal Investigator
  affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
  last name: Wenbo Meng, M.D.
  phone: 13919177177
  email: mengwb@lzu.edu.cn
  last name: Baoping Zhang, M.D.
  phone: +8613893454820
  email: zhangbp21@lzu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24.
  PMID: 27433395
  citation: Wu CH, Huang KH, Chen MH, Fang WL, Chao Y, Lo SS, Li AF, Wu CW, Shyr YM. Comparison of the Long-term Outcome Between Billroth-I and Roux-en-Y Reconstruction Following Distal Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2021 Aug;25(8):1955-1961. doi: 10.1007/s11605-020-04867-1. Epub 2020 Nov 17.
  PMID: 33205309
  responsible party type: Principal Investigator
  investigator affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
  investigator full name: Wenbo Meng
  investigator title: Director of Surgery
  mesh term: Stomach Neoplasms
  mesh term: Gallstones
  mesh term: Cholelithiasis
  mesh term: Cholecystolithiasis
  sharing ipd: No