Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT03490383
Collaborator
(none)
60
1
13.4
4.5
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
ERCP Based Study of Microbiota in Bile From Patients With Common Bile Duct Stone
Actual Study Start Date
:
Feb 16, 2017
Anticipated Primary Completion Date
:
Apr 1, 2018
Anticipated Study Completion Date
:
Apr 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- microbiota in bile [intraoperative]
16s RNA
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- CBD tumor or CBD calculi
Exclusion Criteria:
- contraindication for ERCP
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shang General Hospital | Shanghai | China | 200080 |
Sponsors and Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
- Principal Investigator: Hang Zhao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Zhaohang,
Dr.,
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT03490383
Other Study ID Numbers:
- CBD stone and microbiota
First Posted:
Apr 6, 2018
Last Update Posted:
Apr 6, 2018
Last Verified:
Apr 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhaohang,
Dr.,
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Additional relevant MeSH terms: