Treatment Strategy for Adult Congenital Biliary Dilation

NCT ID: NCT07336576

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Biliary Dilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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underwent surgical treatment for CBD between November 2014 and October 2024

hepatectomy、liver transplantation、hepaticojejunostomy

Intervention Type PROCEDURE

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

Interventions

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hepatectomy、liver transplantation、hepaticojejunostomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shuo Jin

Associate Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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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, China

Site Status

Countries

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China

Other Identifiers

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25534-0-01

Identifier Type: -

Identifier Source: org_study_id

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