ClinicalTrials.gg
CompletedNCT07336576Updated Jan 13, 2026

Treatment Strategy for Adult Congenital Biliary Dilation

An observational study in Congenital Biliary Dilation, sponsored by Beijing Tsinghua Chang Gung Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
234
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Congenital Biliary Dilation

Browse trials for

Keywords

  • Choledochal Cyst
03

In context

Choledochal Cyst

22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.

This study's enrollment of 234 is below the median of 400 across 14 observational studies indexed under Choledochal Cyst.

Browse Choledochal Cyst studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Eligibility criteria

Inclusion Criteria :

  1. Age: Adults (≥18 years).
  2. Study population: Consecutive patients treated at Beijing Tsinghua Changgung Hospital.
  3. Time frame: Underwent surgical treatment between November 2014 and October 2024.
  4. Condition/Procedure: Underwent surgical treatment for common bile duct (CBD) diseases.
  5. 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:

  1. benign stricture,
  2. malignant stricture,
  3. obstructive stones.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
234 participants (actual)
Patient registry
No

Groups and cohorts

  • underwent surgical treatment for CBD between November 2014 and October 2024

    Procedure: hepatectomy、liver transplantation、hepaticojejunostomy

Interventions

  • Procedurehepatectomy、liver transplantation、hepaticojejunostomy

    resection of the diseased bile duct, elimination of secondary lesions, and restoration of biliary-enteric continuity.

06

What researchers measure

Primary outcomes

  1. The modified Mayo Clinic score for CBD

    Patients were stratified into excellent, good, fair, and poor categories based on established criteria

    Time frame: Last follow-up time (assessed up to 10 year)

Secondary outcomes

  1. 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

    Time frame: Perioperative period(Within 3 months after surgery)

  2. 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.

    Time frame: Last follow-up time (assessed up to 10 year)

07

Study locations

1 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, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07336576
Responsible party
Shuo Jin (Associate Chief Physician, Beijing Tsinghua Chang Gung Hospital) — Principal investigator
First posted
Jan 13, 2026
Start date
Oct 1, 2024
Primary completion
Jun 1, 2025
Completion
Jul 1, 2025
Last update
Jan 13, 2026

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 Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion