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临床试验/NCT07336576
NCT07336576已完成不适用

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

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2024年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
234
试验地点
1
主要终点
The modified Mayo Clinic score for CBD

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: Adults (≥18 years).
  • Study population: Consecutive patients treated at Beijing Tsinghua Changgung Hospital.
  • Time frame: Underwent surgical treatment between November 2014 and October
  • 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.

排除标准

  • 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.

研究组 & 干预措施

underwent surgical treatment for CBD between November 2014 and October 2024

干预措施: hepatectomy、liver transplantation、hepaticojejunostomy (Procedure)

结局指标

主要结局

The modified Mayo Clinic score for CBD

时间窗: Last follow-up time (assessed up to 10 year)

Patients were stratified into excellent, good, fair, and poor categories based on established criteria

次要结局

  • perioperative complications(Perioperative period(Within 3 months after surgery))
  • long-term disease-free survival(Last follow-up time (assessed up to 10 year))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuo Jin

Associate Chief Physician

Beijing Tsinghua Chang Gung Hospital

研究点 (1)

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