Congenital Biliary DilationNCT07336576
Treatment Strategy for Adult Congenital Biliary Dilation
An observational study of Congenital Biliary Dilation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
The management of congenital biliary dilations (CBDs), including choledochal cysts, represents one of the most challenging areas in hepatobiliary surgery due to their potential implications for long-term morbidity and malignant transformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Biliary Dilation
- What is being tested?
- hepatectomy、liver transplantation、hepaticojejunostomy
- Type of treatment
- Surgery or procedure
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients who underwent surgical treatment for common bile duct (CBD) diseases between November 2014 and October 2024 at Beijing Tsinghua Changgung Hospital.
Who may be able to join
- Age: Adults (≥18 years).
- Study population: Consecutive patients treated at Beijing Tsinghua Changgung Hospital.
- Time frame: Underwent surgical treatment between November 2014 and October 2024.
- Condition/Procedure: Underwent surgical treatment for common bile duct (CBD) diseases.
- Diagnostic confirmation: Presence, location, and extent of CBD dilatation were diagnosed by preoperative imaging/radiology, and confirmed intraoperatively. Exclusion Criteria ：
- 1.Secondary biliary dilatation due to proximal obstruction, including intrahepatic and/or extrahepatic bile duct dilatation caused by proximal biliary obstruction, such as:
Show all 9Show fewer
- benign stricture,
- malignant stricture,
- obstructive stones.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Key Laboratory of Digital Intelligence Hepatology, Ministry of Education, School of Clinical Medicine, Tsinghua University, Beijing, China
Beijing, Beijing Municipality, 100000
About this study
Official title: Surgery-Oriented Classification and Treatment Strategy for Adult Congenital Biliary Dilation
The management of congenital biliary dilations (CBDs), including choledochal cysts, represents one of the most challenging areas in hepatobiliary surgery due to their potential implications for long-term morbidity and malignant transformation. While CBDs have a relatively low incidence in Western populations (1/150,000-1/100,000), the prevalence is notably higher in Asian countries (1/1,000), making it a significant global health concern. Although complete surgical resection remains the standard of care, the optimal extent of resection and reconstruction strategy, particularly for complex disease patterns, continues to be debated. To address these challenges, the current study proposes a novel surgery-oriented classification system for adult CBD based on the analysis of 234 consecutive cases.
- Conditions
- Congenital Biliary Dilation
- Being tested
- hepatectomy、liver transplantation、hepaticojejunostomy
- Keywords
- Choledochal Cyst
- Medical subject headings
- Choledochal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomy、liver transplantation、hepaticojejunostomyProcedure or surgery
resection of the diseased bile duct, elimination of secondary lesions, and restoration of biliary-enteric continuity.
| Study group | Role | What they receive |
|---|---|---|
| underwent surgical treatment for CBD between November 2014 and October 2024 | Not described Receives: Procedure: hepatectomy、liver transplantation、hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Mayo Clinic score for CBD
Patients were stratified into excellent, good, fair, and poor categories based on established criteria
Measured: Last follow-up time (assessed up to 10 year)
Secondary outcomes (2)
perioperative complications
graded according to the Clavien-Dindo classification,23 specific complications assessed using the International Study Group of Liver Surgery (ISGLS) criteria, including posthepatectomy liver dysfunction, bile leakage, and pancreatic leakage24-26
Measured: Perioperative period（Within 3 months after surgery）
long-term disease-free survival
long-term disease-free survival defined as the interval from surgery to the first occurrence of any of the following events: cholangitis episode, bile stone formation, cholangiocarcinoma development, any long-term complications related to biliary surgery, or death from any cause.
Measured: Last follow-up time (assessed up to 10 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Oct 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Biliary DilationStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 234 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336576
- Sponsor's protocol ID
- 25534-0-01
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery-Oriented Classification and Treatment Strategy for Adult Congenital Biliary Dilation
- ClinicalTrials.gov ID
- NCT07336576
- Acronym / sponsor ID
- 25534-0-01
- Conditions
- Congenital Biliary Dilation
- Keywords
- Choledochal Cyst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 13 Jan 2026 (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.
The management of congenital biliary dilations (CBDs), including choledochal cysts, represents one of the most challenging areas in hepatobiliary surgery due to their potential implications for long-term morbidity and malignant transformation. While CBDs have a relatively low incidence in Western populations (1/150,000-1/100,000), the prevalence is notably higher in Asian countries (1/1,000), making it a significant global health concern. Although complete surgical resection remains the standard of care, the optimal extent of resection and reconstruction strategy, particularly for complex disease patterns, continues to be debated. To address these challenges, the current study proposes a novel surgery-oriented classification system for adult CBD based on the analysis of 234 consecutive cases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| underwent surgical treatment for CBD between November 2014 and October 2024 | – | Procedure: hepatectomy、liver transplantation、hepaticojejunostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients who underwent surgical treatment for common bile duct (CBD) diseases between November 2014 and October 2024 at Beijing Tsinghua Changgung Hospital.
Key inclusion criteria (9 listed)
- Age: Adults (≥18 years).
- Study population: Consecutive patients treated at Beijing Tsinghua Changgung Hospital.
- Time frame: Underwent surgical treatment between November 2014 and October 2024.
- Condition/Procedure: Underwent surgical treatment for common bile duct (CBD) diseases.
- Diagnostic confirmation: Presence, location, and extent of CBD dilatation were diagnosed by preoperative imaging/radiology, and confirmed intraoperatively. Exclusion Criteria ：
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatectomy、liver transplantation、hepaticojejunostomyresection of the diseased bile duct, elimination of secondary lesions, and restoration of biliary-enteric continuity. | Procedure or surgery | underwent surgical treatment for CBD between November 2014 and October 2024 |
Primary outcome
The modified Mayo Clinic score for CBD
Time frame: Last follow-up time (assessed up to 10 year)
Patients were stratified into excellent, good, fair, and poor categories based on established criteria
2 secondary outcomes
perioperative complications
Time frame: Perioperative period（Within 3 months after surgery）
long-term disease-free survival
Time frame: Last follow-up time (assessed up to 10 year)
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 13 Jan 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Congenital Biliary Dilation, 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 9 inclusion and 0 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 13 Jan 2026. 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?
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?
The modified Mayo Clinic score for CBD (time frame: Last follow-up time (assessed up to 10 year)). 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 13 Jan 2026.