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Treatment Strategy for Adult Congenital Biliary Dilation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07336576
Enrollment
234
Registered
2026-01-13
Start date
2024-10-01
Completion date
2025-07-01
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Biliary Dilation

Keywords

Choledochal Cyst

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.

Interventions

PROCEDUREhepatectomy、liver transplantation、hepaticojejunostomy

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

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The modified Mayo Clinic score for CBDLast follow-up time (assessed up to 10 year)Patients were stratified into excellent, good, fair, and poor categories based on established criteria

Secondary

MeasureTime frameDescription
perioperative complicationsPerioperative 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
long-term disease-free survivalLast 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026