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Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

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ClinicalTrials.gov Identifier: NCT03836170
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Procedure: Laparoscopic cholecystectomy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Analysis by High-throughput Sequencing: the Impact of Cholecystectomy on Gut Microbiome in Adults
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 20, 2019
Estimated Study Completion Date : June 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Laparoscopic cholecystectomy
A laparoscopic cholecystectomy was performed to remove the gallbladder
 Procedure: Laparoscopic cholecystectomy
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of gut microbiota after laparoscopic cholecystectomy [ Time Frame: Three months and one year after completion of LC ]
    Three months and one year after completion of laparoscopic cholecystectomy therapy, gut microbiota was assessed by 16S rDNA high-throughput sequencing.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Gallbladder polyps diameter mm >10;
  2. The history of the symptoms of patients with gallbladder stones, there was no history of acute attack in the past month;
  3. Age <70 years old;
  4. No serious systemic diseases such as diabetes, hypertension, heart disease, lung disease and so on/American anesthesia Association (ASA) grade I or II;
  5. BMI<30;
  6. Families have better care and observation, and away from the hospital within 1 hours; patients and their families understand the process of ambulatory surgery (24 hours) and the pros and cons.

Exclusion Criteria:

  1. Less than 18 years old;
  2. With previous gastric surgery ;
  3. Major systemic diseases ;
  4. Pregnancy or lactation;
  5. The use of antibiotics or yogurt within 2 months before the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836170


Contacts
Contact: Yingjie Ji, M.D. 86+15800575527 jiyingjie39@outlook.com

Locations
China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Yingjie Ji, M.D.    86+15800575527    jiyingjie39@outlook.com   
Principal Investigator: Hong Lu, M.D.,Ph.D.         
Sub-Investigator: Yingjie Ji, M.D.         
Sub-Investigator: Hui Wang, M.D.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Hong Lu, M.D. Renji Hospital, School of Medicine, Shanghai Jiao Tong University
More Information
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Responsible Party: Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03836170     History of Changes
Other Study ID Numbers: rjkls20190208
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hong Lu, MD, Shanghai Jiao Tong University School of Medicine:
laparoscopic cholecystectomy
gut microbiota