Choledochal CystNCT07152496
Host-Microbe Interactions in Biliary Dilatation
An observational study of Choledochal Cyst, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This study is an observational cohort study aimed at continuously enrolling patients with biliary dilatation and healthy controls. It will collect bile duct tissue samples and clinical data from participants across all age groups to establish a comprehensive cohort for biliary dilatation research. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Choledochal Cyst
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Disease Group: Patients diagnosed with biliary dilatation who are scheduled for surgical resection. These participants represent the primary study population for investigating the molecular mechanisms and microbiome characteristics associated with biliary dilatation. Control Group: Healthy donor bile duct tissues that are routinely discarded during organ transplantation surgical procedures. These tissues represent normal bile duct samples that are removed as part of standard surgical preparation but are not used for transplantation, serving as healthy controls for comparison of transcriptome and microbiome profiles.
Who may be able to join
- Patients who have been definitively diagnosed with biliary dilatation and are scheduled for surgical resection (Disease group) Healthy donor bile duct tissues discarded during organ transplantation procedures as part of routine surgical preparation (Control group)
Who cannot join
- Patients with severe systemic diseases that may affect study outcomes (Disease group) Insufficient tissue sample quality or quantity (Disease group) Unavailable or inadequate donor bile duct tissue samples (Control group)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shuo Jin contact
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official title: Integrated Transcriptome-Microbiome Profiling Reveals Host-Microbe Crosstalk in Biliary Dilatation
This study is an observational cohort study aimed at continuously enrolling patients with biliary dilatation and healthy controls. It will collect bile duct tissue samples and clinical data from participants across all age groups to establish a comprehensive cohort for biliary dilatation research. Based on this cohort, the study seeks to investigate the molecular mechanisms underlying biliary dilatation development and progression, explore the role of host-microbiome interactions in disease processes, and identify biomarkers associated with complications and malignancy risk, to establish evidence-based strategies for improved diagnosis and treatment of biliary dilatation.
Read the detailed description
Biliary dilatation (BD) is a complex bile duct disease that affects people differently around the world. In Asia, about 1 in every 1,000 people have this condition. In Europe and America, it is much less common, affecting about 1 in every 50,000 to 150,000 people.
People with biliary dilatation face serious health risks. Up to 80% of patients develop complications such as bile duct inflammation (cholangitis) and bile duct stones. Even more concerning, about 30% of patients may develop cancer, and this risk increases with age. Even after surgery to remove the affected bile ducts, patients still face ongoing risks. About 35% continue to have problems with gallstones and bile duct inflammation. Their risk of developing cancer remains 120 to 200 times higher than healthy people, with cancer rates reaching 14.9%.
Despite these serious risks, researchers do not fully understand why biliary dilatation happens, how it gets worse over time, or why it leads to so many complications and such high cancer risk. Very few studies have looked at this disease at the molecular level. One study that examined genes did not find typical genetic changes. Other small studies looking at gene activity and proteins were limited by having too few patients and no comparison groups, so they could not find clear biological patterns.
Recent research has shown that bacteria and other microorganisms play important roles in many bile duct diseases, including bile duct stones, inflammation, and cancer. Because these microorganisms affect so many bile duct conditions, we believe they may also be important in biliary dilatation.
This study aims to create two groups of participants: people with biliary dilatation of all ages and a control group of healthy people. We will collect bile duct tissue samples from patients who have surgery to remove diseased bile ducts and from healthy donor bile duct tissue that would otherwise be discarded during organ transplant surgeries.
Through studying these tissue samples, our research team will work to understand how biliary dilatation develops and gets worse, why complications happen, and what role bacteria and other microorganisms play in this disease process.
- Conditions
- Choledochal Cyst
- Keywords
- molecular mechanism, Biliary Dilatation, microbiome
- Medical subject headings
- Choledochal Cyst
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 |
|---|---|---|
| This group included BD patients | Not described | |
| This group included healthy control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular mechanisms
Identification of differentially expressed genes and altered molecular pathways in biliary dilatation through integrated transcriptome analysis of bile duct tissue samples, measured by RNA sequencing and bioinformatics analysis.
Measured: At the time of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledochal CystStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo Jin, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Shuo Jin, Principal Investigator, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152496
- Sponsor's protocol ID
- 24756-0-01
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Transcriptome-Microbiome Profiling Reveals Host-Microbe Crosstalk in Biliary Dilatation
- ClinicalTrials.gov ID
- NCT07152496
- Acronym / sponsor ID
- 24756-0-01
- Conditions
- Choledochal Cyst
- Keywords
- molecular mechanism, Biliary Dilatation, microbiome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Sep 2025 (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.
This study is an observational cohort study aimed at continuously enrolling patients with biliary dilatation and healthy controls. It will collect bile duct tissue samples and clinical data from participants across all age groups to establish a comprehensive cohort for biliary dilatation research. Based on this cohort, the study seeks to investigate the molecular mechanisms underlying biliary dilatation development and progression, explore the role of host-microbiome interactions in disease processes, and identify biomarkers associated with complications and malignancy risk, to establish evidence-based strategies for improved diagnosis and treatment of biliary dilatation.
Detailed description
Biliary dilatation (BD) is a complex bile duct disease that affects people differently around the world. In Asia, about 1 in every 1,000 people have this condition. In Europe and America, it is much less common, affecting about 1 in every 50,000 to 150,000 people.
People with biliary dilatation face serious health risks. Up to 80% of patients develop complications such as bile duct inflammation (cholangitis) and bile duct stones. Even more concerning, about 30% of patients may develop cancer, and this risk increases with age. Even after surgery to remove the affected bile ducts, patients still face ongoing risks. About 35% continue to have problems with gallstones and bile duct inflammation. Their risk of developing cancer remains 120 to 200 times higher than healthy people, with cancer rates reaching 14.9%.
Despite these serious risks, researchers do not fully understand why biliary dilatation happens, how it gets worse over time, or why it leads to so many complications and such high cancer risk. Very few studies have looked at this disease at the molecular level. One study that examined genes did not find typical genetic changes. Other small studies looking at gene activity and proteins were limited by having too few patients and no comparison groups, so they could not find clear biological patterns.
Recent research has shown that bacteria and other microorganisms play important roles in many bile duct diseases, including bile duct stones, inflammation, and cancer. Because these microorganisms affect so many bile duct conditions, we believe they may also be important in biliary dilatation.
This study aims to create two groups of participants: people with biliary dilatation of all ages and a control group of healthy people. We will collect bile duct tissue samples from patients who have surgery to remove diseased bile ducts and from healthy donor bile duct tissue that would otherwise be discarded during organ transplant surgeries.
Through studying these tissue samples, our research team will work to understand how biliary dilatation develops and gets worse, why complications happen, and what role bacteria and other microorganisms play in this disease process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| This group included BD patients | – | – |
| This group included healthy control | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Disease Group: Patients diagnosed with biliary dilatation who are scheduled for surgical resection. These participants represent the primary study population for investigating the molecular mechanisms and microbiome characteristics associated with biliary dilatation. Control Group: Healthy donor bile duct tissues that are routinely discarded during organ transplantation surgical procedures. These tissues represent normal bile duct samples that are removed as part of standard surgical preparation but are not used for transplantation, serving as healthy controls for comparison of transcriptome and microbiome profiles.
Key inclusion criteria (1 listed)
- Patients who have been definitively diagnosed with biliary dilatation and are scheduled for surgical resection (Disease group) Healthy donor bile duct tissues discarded during organ transplantation procedures as part of routine surgical preparation (Control group)
Key exclusion criteria (1 listed)
- Patients with severe systemic diseases that may affect study outcomes (Disease group) Insufficient tissue sample quality or quantity (Disease group) Unavailable or inadequate donor bile duct tissue samples (Control group)
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
molecular mechanisms
Time frame: At the time of surgery.
Identification of differentially expressed genes and altered molecular pathways in biliary dilatation through integrated transcriptome analysis of bile duct tissue samples, measured by RNA sequencing and bioinformatics analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Shuo Jin contact
Shuo Jin, Principal Investigator principal investigator
Beijing Tsinghua Changgeng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choledochal Cyst, run by Beijing Tsinghua Chang Gung Hospital at 1 site 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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siqiao Shan (+86 13683156996, dsqs01567@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
molecular mechanisms (time frame: At the time of surgery.). 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 9 Dec 2025.