Study of Microbiota in Bile From Patients With Common Bil... | NCT03490383

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

NCT03490383

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Oct 30, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Cholangiopancreatography, Endoscopic Retrograde
Common Bile Duct Calculi
Microbial Colonization

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2018Actual

Primary Completion Date

Apr 1, 2023Actual

Completion Date

Apr 1, 2023Actual

First Submitted Date

Mar 14, 2018

First Submission Date that Met QC Criteria

Apr 5, 2018

First Posted Date

Apr 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2023

Last Update Posted Date

Oct 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhaohang, Dr., Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microbiota in bile	16s RNA	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CBD tumor or CBD calculi

Exclusion Criteria:

contraindication for ERCP

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

ERCP patients in our center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hang Zhao	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shang General Hospital		Shanghai		200080	China
Shanghai Municipal Hospital of Traditional Chinese Medicine

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones
D003141	Communicable Diseases

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

Browse Leaves

Not provided

Browse Branches

Not provided