<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/NCT03836170</url>
  </required_header>
  <id_info>
    <org_study_id>rjkls20190208</org_study_id>
    <nct_id>NCT03836170</nct_id>
  </id_info>
  <brief_title>Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults</brief_title>
  <official_title>Analysis by High-throughput Sequencing: the Impact of Cholecystectomy on Gut Microbiome in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</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>
      Laparoscopic cholecystectomy (LC) is widely used in the gallbladder stone, gallbladder polyp,&#xD;
      gallbladder cancer and other diseases. Some of the patients would develop diarrhea after&#xD;
      surgery, and studies have reported an increased risk of colorectal cancer after LC. The aim&#xD;
      of the present study was to examine the effects of LC on the gut microbiota.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 20, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of gut microbiota after laparoscopic cholecystectomy</measure>
    <time_frame>Three months and one year after completion of LC</time_frame>
    <description>Three months and one year after completion of laparoscopic cholecystectomy therapy, gut microbiota was assessed by 16S rDNA high-throughput sequencing.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Laparoscopic Cholecystectomy</condition>
  <arm_group>
    <arm_group_label>Laparoscopic cholecystectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A laparoscopic cholecystectomy was performed to remove the gallbladder</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic cholecystectomy</intervention_name>
    <description>A special catheter was inserted into the peritoneal cavity, and then about 2-5 liters of carbon dioxide was injected. After reaching a certain pressure, four small holes of 0.5-1.5cm were opened in the abdomen to dissect the structure of the triangle of the gallbladder. The gallbladder duct and gallbladder artery were cut off and closed, and then the entire gallbladder was removed.</description>
    <arm_group_label>Laparoscopic cholecystectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gallbladder polyps diameter mm &gt;10;&#xD;
&#xD;
          2. The history of the symptoms of patients with gallbladder stones, there was no history&#xD;
             of acute attack in the past month;&#xD;
&#xD;
          3. Age &lt;70 years old;&#xD;
&#xD;
          4. No serious systemic diseases such as diabetes, hypertension, heart disease, lung&#xD;
             disease and so on/American anesthesia Association (ASA) grade I or II;&#xD;
&#xD;
          5. BMI&lt;30;&#xD;
&#xD;
          6. Families have better care and observation, and away from the hospital within 1 hours;&#xD;
             patients and their families understand the process of ambulatory surgery (24 hours)&#xD;
             and the pros and cons.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Less than 18 years old;&#xD;
&#xD;
          2. With previous gastric surgery ;&#xD;
&#xD;
          3. Major systemic diseases ;&#xD;
&#xD;
          4. Pregnancy or lactation;&#xD;
&#xD;
          5. The use of antibiotics or yogurt within 2 months before the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Lu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renji Hospital, School of Medicine, Shanghai Jiao Tong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yingjie Ji, M.D.</last_name>
    <phone>86+15800575527</phone>
    <email>jiyingjie39@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Renji Hospital, School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yingjie Ji, M.D.</last_name>
      <phone>86+15800575527</phone>
      <email>jiyingjie39@outlook.com</email>
    </contact>
    <investigator>
      <last_name>Hong Lu, M.D.,Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yingjie Ji, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hui Wang, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Hong Lu, MD</investigator_full_name>
    <investigator_title>Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>laparoscopic cholecystectomy</keyword>
  <keyword>gut microbiota</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03836170
org study id: rjkls20190208
nct id: NCT03836170
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Laparoscopic cholecystectomy (LC) is widely used in the gallbladder stone, gallbladder polyp,
      gallbladder cancer and other diseases. Some of the patients would develop diarrhea after
      surgery, and studies have reported an increased risk of colorectal cancer after LC. The aim
      of the present study was to examine the effects of LC on the gut microbiota.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change of gut microbiota after laparoscopic cholecystectomy
time frame: Three months and one year after completion of LC
description: Three months and one year after completion of laparoscopic cholecystectomy therapy, gut microbiota was assessed by 16S rDNA high-throughput sequencing.
arm group label: Laparoscopic cholecystectomy
arm group type: Experimental
description: A laparoscopic cholecystectomy was performed to remove the gallbladder
intervention type: Procedure
intervention name: Laparoscopic cholecystectomy
description: A special catheter was inserted into the peritoneal cavity, and then about 2-5 liters of carbon dioxide was injected. After reaching a certain pressure, four small holes of 0.5-1.5cm were opened in the abdomen to dissect the structure of the triangle of the gallbladder. The gallbladder duct and gallbladder artery were cut off and closed, and then the entire gallbladder was removed.
arm group label: Laparoscopic cholecystectomy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Lu, M.D.
role: Principal Investigator
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
last name: Yingjie Ji, M.D.
phone: 86+15800575527
email: jiyingjie39@outlook.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Hong Lu, MD
investigator title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
sharing ipd: No