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临床试验/NCT07311798
NCT07311798尚未招募不适用

Impact of Vascular Resection on Survival and Postoperative Outcomes in Patients With Hilar Cholangiocarcinoma: A Retrospective Study

Yongjun Chen0 个研究点目标入组 300 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Postoperative Complications Grade II or Higher (Clavien-Dindo ≥ II)

研究概览

简要总结

Hilar cholangiocarcinoma is a highly aggressive malignancy, and surgical resection remains the only potentially curative treatment. Due to the frequent involvement of major vascular structures, vascular resection is increasingly performed to achieve negative surgical margins; however, its impact on survival and postoperative outcomes remains controversial. This retrospective study aims to evaluate the association between vascular resection and clinical outcomes, including survival and postoperative outcomes, in patients with hilar cholangiocarcinoma undergoing curative-intent surgery.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who underwent surgical treatment at the Department of Hepatobiliary and Pancreatic Surgery of our hospital between January 2010 and December 2024, including those with or without concomitant vascular resection.
  • Pathologically confirmed diagnosis of hilar cholangiocarcinoma after surgery.
  • Complete clinical and follow-up data available for outcome analysis.

排除标准

  • Patients with distant metastasis or who underwent only palliative or exploratory surgery.
  • Patients diagnosed preoperatively or intraoperatively with other types of biliary malignancies not located at the hilar region.
  • Patients with incomplete medical records or missing key clinical or follow-up data.

结局指标

主要结局

Postoperative Complications Grade II or Higher (Clavien-Dindo ≥ II)

时间窗: Within 30 days after surgery

Postoperative complications within 30 days after surgery will be assessed and classified according to the Clavien-Dindo classification system. Grade II or higher complications are defined as complications requiring pharmacological treatment, blood transfusion, interventional procedures, reoperation, intensive care management, or resulting in death.

Overall Survival (OS)

时间窗: From surgery to death or last follow-up (up to 5 years)

Time from the date of curative-intent surgery to death from any cause or last follow-up. Patients who are alive at the last follow-up will be censored. Survival data will be collected from medical records and follow-up visits.

次要结局

  • Perioperative Mortality(30 days after surgery or during hospitalization)
  • Length of Postoperative Hospital Stay(From the date of surgery to hospital discharge, assessed up to 90 days.)
  • Intraoperative Blood Loss(During surgery)
  • Disease-Free Survival (DFS)(From surgery to tumor recurrence, metastasis, death, or last follow-up (up to 5 years))

研究者

发起方
Yongjun Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yongjun Chen

Director

Tongji Hospital

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