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Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP

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ClinicalTrials.gov Identifier: NCT03490383
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Zhaohang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
In this study, investigators will investigate the microbiota of bile in common bile duct stone participants. Three key questions are of concern. The first one is whether there is bacteriria in bile in participants without common bile duct stone. The second one is whether the microbiota of bile is similar with that of gut mucosa in common bile duct stone participants. The third one is whether the bacteria in bile of common bile participants with intact papillar is the same as that of participants underwent sphinctomy.

Condition or disease
Cholangiopancreatography, Endoscopic Retrograde Common Bile Duct Calculi Microbial Colonization

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: ERCP Based Study of Microbiota in Bile From Patients With Common Bile Duct Stone
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Group/Cohort
patients without CBD calculi
patients without CBD calculi
CBD calculi without ERCP history
patients with CBD calculi without ERCP history
CBD calculi with ERCP history
patients with CBD calculi and ERCP history



Primary Outcome Measures :
  1. microbiota in bile [ Time Frame: intraoperative ]
    16s RNA



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ERCP patients in our center
Criteria

Inclusion Criteria:

  • CBD tumor or CBD calculi

Exclusion Criteria:

  • contraindication for ERCP

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): NCT03490383


Contacts
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Contact: Hang Zhao, Professor 18621186288 drzhaohang@163.com

Locations
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China
Shang General Hospital Recruiting
Shanghai, China, 200080
Contact: Hang Zhao    18621186288    drzhaohang@163.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Hang Zhao Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Additional Information:

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Responsible Party: Zhaohang, Dr., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03490383     History of Changes
Other Study ID Numbers: CBD stone and microbiota
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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

Keywords provided by Zhaohang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
ERCP
CBD stone
Microbial Colonization

Additional relevant MeSH terms:
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Calculi
Communicable Diseases
Infection
Gallstones
Pathological Conditions, Anatomical
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases