Treatment Strategy for Adult Congenital Biliary Dilation

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.

Study Overview

• Status: Completed
• Conditions: Congenital Biliary Dilation
• Intervention / Treatment: Procedure: hepatectomy、liver transplantation、hepaticojejunostomy

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Key Laboratory of Digital Intelligence Hepatology, Ministry of Education, School of Clinical Medicine, Tsinghua University, Beijing, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
underwent surgical treatment for CBD between November 2014 and October 2024	Procedure: hepatectomy、liver transplantation、hepaticojejunostomy; resection of the diseased bile duct, elimination of secondary lesions, and restoration of biliary-enteric continuity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The modified Mayo Clinic score for CBD	Patients were stratified into excellent, good, fair, and poor categories based on established criteria	Last follow-up time (assessed up to 10 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Last follow-up time (assessed up to 10 year)

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Choledochal Cyst
• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Congenital Abnormalities; Cysts; Bile Duct Diseases; Digestive System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Choledochal Cyst
• Other Study ID Numbers: 25534-0-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No