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NCT Number: NCT07336576

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.

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Key information

Conditions

Congenital Biliary Dilation Bile Duct Diseases Biliary Tract Diseases Choledochal Cyst Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Digestive System Abnormalities Digestive System Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

：

  • 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:

  • benign stricture,
  • malignant stricture,
  • obstructive stones.

Treatment and study plan

hepatectomy、liver transplantation、hepaticojejunostomy

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. perioperative complications

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

    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

  2. long-term disease-free survival

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

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Surgery-Oriented Classification and Treatment Strategy for Adult Congenital Biliary Dilation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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