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NCT Number: NCT07311798

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

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.

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Key information

Who can participate

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No Intervention: Observational Cohort

Other

This is an observational study. No intervention is assigned.

Primary outcomes

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

    Time frame: 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.

  2. Overall Survival (OS)

    Time frame: 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.

Secondary outcomes

  1. Perioperative Mortality

    Time frame: 30 days after surgery or during hospitalization

    Death occurring within 30 days after surgery or during the index hospitalization, whichever occurs later.

  2. Length of Postoperative Hospital Stay

    Time frame: From the date of surgery to hospital discharge, assessed up to 90 days.

    Number of days from the date of surgery to hospital discharge.

  3. Intraoperative Blood Loss

    Time frame: During surgery

    Estimated blood loss recorded in the operative report, measured in milliliters.

  4. Disease-Free Survival (DFS)

    Time frame: From surgery to tumor recurrence, metastasis, death, or last follow-up (up to 5 years)

    Time from surgery to tumor recurrence, metastasis, death from any cause, or last follow-up, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Yongjun Chen

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

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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