Cholangiopancreatography, Endoscopic RetrogradeNCT03490383
Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Common Bile Duct Calculi, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct Calculi, Microbial Colonization
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 16 Feb 2018to 1 Apr 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ERCP patients in our center
Who may be able to join
- CBD tumor or CBD calculi
Who cannot join
- contraindication for ERCP
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shang General Hospital
Shanghai, 200080
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai
About this study
Official title: ERCP Based Study of Microbiota in Bile From Patients With Common Bile Duct Stone
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.
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct Calculi, Microbial Colonization
- Keywords
- ERCP, CBD stone, Microbial Colonization
- Medical subject headings
- Gallstones, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiota in bile
16s RNA
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start16 Feb 2018
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hang Zhao, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490383
- Sponsor's protocol ID
- CBD stone and microbiota
- Status last verified
- Oct 2023
- First submitted
- 14 Mar 2018
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERCP Based Study of Microbiota in Bile From Patients With Common Bile Duct Stone
- ClinicalTrials.gov ID
- NCT03490383
- Acronym / sponsor ID
- CBD stone and microbiota
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct Calculi, Microbial Colonization
- Keywords
- ERCP, CBD stone, Microbial Colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ERCP patients in our center
Key inclusion criteria (1 listed)
- CBD tumor or CBD calculi
Key exclusion criteria (1 listed)
- contraindication for ERCP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
microbiota in bile
Time frame: intraoperative
16s RNA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
Related trials for Cholangiopancreatography, Endoscopic Retrograde
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
Not yet recruiting
XRAIconnect Image Guidance Software for ERCP Procedures
Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
Recruiting
Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
Anesthesia, Sedation
Not yet recruiting
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hang Zhao principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Common Bile Duct Calculi, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiota in bile (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.