NCT03490383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

5.1 years

First QC Date

March 14, 2018

Last Update Submit

October 26, 2023

Conditions

Cholangiopancreatography, Endoscopic RetrogradeCommon Bile Duct CalculiMicrobial Colonization

Keywords

ERCPCBD stoneMicrobial Colonization

Outcome Measures

Primary Outcomes (1)

  • microbiota in bile

    16s RNA

    intraoperative

Study Arms (3)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ERCP patients in our center

You may qualify if:

  • CBD tumor or CBD calculi

You may not qualify if:

  • contraindication for ERCP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shang General Hospital

Shanghai, 200080, China

Location

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, China

Location

MeSH Terms

Conditions

GallstonesCommunicable Diseases

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfectionsDisease AttributesPathologic Processes

Study Officials

  • Hang Zhao

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 14, 2018

First Posted

April 6, 2018

Study Start

February 16, 2018

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

CN(2)