Congenital Biliary DilatationNCT07903077
Clinical Spectrum and Long-term Outcomes of Congenital Biliary Dilatation
An observational study of Congenital Biliary Dilatation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Congenital biliary dilatation affects children and adults and can cause biliary complications and malignancy. Large multicenter data on its clinical characteristics and long-term outcomes are limited. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Biliary Dilatation
- How many people
- 4,341 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Sep 2026
- 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: All patients with confirmed CBD were included in the baseline analysis.
Who may be able to join
- Consecutive inpatients and outpatients diagnosed with CBD.
Who cannot join
- Secondary biliary dilatation attributable to obstructing stones;
- Benign or malignant strictures, or other acquired biliary dilation without evidence of congenital disease was excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official title: Clinical Spectrum and Long-term Outcomes of Congenital Biliary Dilatation: A 20-Year Nationwide Multicenter Study of 4,341 Patients
Congenital biliary dilatation affects children and adults and can cause biliary complications and malignancy. Large multicenter data on its clinical characteristics and long-term outcomes are limited. Therefore, we conduct this study to characterize the clinical presentation and long-term outcomes of congenital biliary dilatation and identify factors associated with long-term complications.
Design, Setting, and Participants
Read the detailed description
Congenital biliary dilatation (CBD) comprises a group of congenital abnormalities involving segmental or diffuse dilatation of the intrahepatic and/or extrahepatic bile ducts. It can present in both children and adults and may lead to cholangitis, pancreatitis, biliary stones, liver injury, and biliary malignancy. Surgical treatment is the mainstay of management, with the operative approach determined by the extent and location of disease. However, treatment does not eliminate the risk of later complications. Previous studies have reported recurrent cholangitis, hepatolithiasis, anastomotic stricture, reoperation, and biliary cancer after surgery.
Evidence on the long-term course of CBD remains limited. Most studies have focused on selected age groups, specific Todani types, individual surgical techniques, or single outcomes. In a multi-institutional study of 394 patients, Soares et al. found differences in presentation and perioperative outcomes between children and adults and reported biliary cancer during follow-up after resection. Other studies have shown that type IVa disease may remain complicated by intrahepatic stones, recurrent cholangitis, and reoperation because abnormal intrahepatic ducts remain after treatment. Type V disease has usually been studied separately because of its different intrahepatic distribution and the need for liver-directed treatment in selected patients. No large multicenter cohort has comprehensively characterized the clinical spectrum and long-term outcomes across the major anatomical phenotypes of CBD.
We therefore conducted a nationwide multicenter cohort study to characterize the clinical features and long-term outcomes of patients with CBD. We examined differences across anatomical types, described perioperative and long-term outcomes after surgery, and evaluated factors associated with long-term complications. Long-term complication-free survival (LCFS) was the primary outcome, defined by the time to the first long-term biliary, pancreatic, hepatic, or malignant complication after surgery.
- Conditions
- Congenital Biliary Dilatation
- Keywords
- Congenital biliary dilatation, pancreaticobiliary maljunction, long-term outcomes, reoperation, biliary cancer
- Medical subject headings
- Choledochal Cyst, Pancreaticobiliary Maljunction, Biliary Tract Neoplasms
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 diagnosed with congenital biliary dilatation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term complication-free survival
Long-term complications were defined as events occurring more than 3 months after the initial operation and included recurrent cholangitis, pancreatitis, bilioenteric anastomotic stricture, extrahepatic or intrahepatic bile duct stones, liver atrophy, hepatic decompensation, and postoperative biliary cancer.
Measured: LCFS was calculated from the date of the initial operation to the first long-term complication or the last available follow-up. Time zero was postoperative Day 1. Time frame was through study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jun 2026
- Primary completion30 Aug 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Biliary DilatationStudies 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
- 4,341 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
- NCT07903077
- Sponsor's protocol ID
- S02455-01
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Concerning patients privacy.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Spectrum and Long-term Outcomes of Congenital Biliary Dilatation: A 20-Year Nationwide Multicenter Study of 4,341 Patients
- ClinicalTrials.gov ID
- NCT07903077
- Acronym / sponsor ID
- S02455-01
- Conditions
- Congenital Biliary Dilatation
- Keywords
- Congenital biliary dilatation, pancreaticobiliary maljunction, long-term outcomes, reoperation, biliary cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,341 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 29 Oct 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.
Congenital biliary dilatation affects children and adults and can cause biliary complications and malignancy. Large multicenter data on its clinical characteristics and long-term outcomes are limited. Therefore, we conduct this study to characterize the clinical presentation and long-term outcomes of congenital biliary dilatation and identify factors associated with long-term complications.
Design, Setting, and Participants
Detailed description
Congenital biliary dilatation (CBD) comprises a group of congenital abnormalities involving segmental or diffuse dilatation of the intrahepatic and/or extrahepatic bile ducts. It can present in both children and adults and may lead to cholangitis, pancreatitis, biliary stones, liver injury, and biliary malignancy. Surgical treatment is the mainstay of management, with the operative approach determined by the extent and location of disease. However, treatment does not eliminate the risk of later complications. Previous studies have reported recurrent cholangitis, hepatolithiasis, anastomotic stricture, reoperation, and biliary cancer after surgery.
Evidence on the long-term course of CBD remains limited. Most studies have focused on selected age groups, specific Todani types, individual surgical techniques, or single outcomes. In a multi-institutional study of 394 patients, Soares et al. found differences in presentation and perioperative outcomes between children and adults and reported biliary cancer during follow-up after resection. Other studies have shown that type IVa disease may remain complicated by intrahepatic stones, recurrent cholangitis, and reoperation because abnormal intrahepatic ducts remain after treatment. Type V disease has usually been studied separately because of its different intrahepatic distribution and the need for liver-directed treatment in selected patients. No large multicenter cohort has comprehensively characterized the clinical spectrum and long-term outcomes across the major anatomical phenotypes of CBD.
We therefore conducted a nationwide multicenter cohort study to characterize the clinical features and long-term outcomes of patients with CBD. We examined differences across anatomical types, described perioperative and long-term outcomes after surgery, and evaluated factors associated with long-term complications. Long-term complication-free survival (LCFS) was the primary outcome, defined by the time to the first long-term biliary, pancreatic, hepatic, or malignant complication after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with congenital biliary dilatation | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with confirmed CBD were included in the baseline analysis.
Key inclusion criteria (1 listed)
- Consecutive inpatients and outpatients diagnosed with CBD.
Key exclusion criteria (2 listed)
- Secondary biliary dilatation attributable to obstructing stones;
- Benign or malignant strictures, or other acquired biliary dilation without evidence of congenital disease was excluded.
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
Long-term complication-free survival
Time frame: LCFS was calculated from the date of the initial operation to the first long-term complication or the last available follow-up. Time zero was postoperative Day 1. Time frame was through study completion, an average of 5 years.
Long-term complications were defined as events occurring more than 3 months after the initial operation and included recurrent cholangitis, pancreatitis, bilioenteric anastomotic stricture, extrahepatic or intrahepatic bile duct stones, liver atrophy, hepatic decompensation, and postoperative biliary cancer.
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Concerning patients privacy.
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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 Dilatation, 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 2 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 29 Oct 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?
Long-term complication-free survival (time frame: LCFS was calculated from the date of the initial operation to the first long-term complication or the last available follow-up. Time zero was postoperative Day 1. Time frame was through study completion, an average of 5 years.). 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 29 Oct 2026.