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CompletedNCT03490383Updated Oct 30, 2023

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

An observational study in Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct Calculi and Microbial Colonization, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 2 sites in China. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study 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.

02

Conditions studied

  • Cholangiopancreatography, Endoscopic Retrograde
  • Common Bile Duct Calculi
  • Microbial Colonization

Keywords

  • ERCP
  • CBD stone
  • Microbial Colonization
03

In context

Gallstones

354 studies on the registry are indexed under Gallstones; 47 are open to participants now.

This study's enrollment of 60 is below the median of 200 across 105 observational studies indexed under Gallstones.

Browse Gallstones studies →

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.

Browse Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ERCP patients in our center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • CBD tumor or CBD calculi

Exclusion criteria

Exclusion Criteria:

  • contraindication for ERCP
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. microbiota in bile

    16s RNA

    Time frame: intraoperative

07

Study locations

2 sites
  • Shang General Hospital
    Shanghai, 200080, China
  • Shanghai Municipal Hospital of Traditional Chinese Medicine
    Shanghai, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Apr 2023, 61 months.

Of 32 non-industry observational studies under Gallstones, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 60. This study's 61 months is above that.

Counting every sponsor, half of 32 studies reached it within 29 months; a quarter within 10 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2018
First posted
Apr 6, 2018
StartActual
Feb 16, 2018
Primary completionActual
Apr 1, 2023
CompletionActual
Apr 1, 2023
Last update
Oct 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03490383
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Zhaohang (Dr., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Apr 6, 2018
Start date
Feb 16, 2018
Primary completion
Apr 1, 2023
Completion
Apr 1, 2023
Last update
Oct 30, 2023

Study contacts

Hang Zhao
principal investigator · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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