Treatment Strategy for Adult Congenital Biliary Dilation

NCT07336576 | Completed

• 1 other identifier: 25534-0-01
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Biliary Dilation

Keywords

Choledochal Cyst

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• perioperative complications

  Perioperative period（Within 3 months after surgery）

• long-term disease-free survival

  Last follow-up time (assessed up to 10 year)

Study Arms (1)

underwent surgical treatment for CBD between November 2014 and October 2024

Procedure: hepatectomy、liver transplantation、hepaticojejunostomy

Interventions

hepatectomy、liver transplantation、hepaticojejunostomy PROCEDURE

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

underwent surgical treatment for CBD between November 2014 and October 2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Secondary biliary dilatation due to proximal obstruction, including intrahepatic and/or extrahepatic bile duct dilatation caused by proximal biliary obstruction, such as:
• benign stricture,
• malignant stricture,
• obstructive stones.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 13, 2026
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)