About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population includes patients who underwent curative-intent surgery for hilar cholangiocarcinoma at the Department of Hepatobiliary and Pancreatic Surgery of our hospital between January 2010 and December 2024. Patients were included regardless of whether vascular resection was performed. All patients had a pathologically confirmed diagnosis of hilar cholangiocarcinoma and sufficient clinical and follow-up data for outcome analysis. Patients with distant metastasis, those who underwent only palliative or exploratory surgery, or those with incomplete medical records or missing key clinical or follow-up information were excluded. According to intraoperative findings, patients were categorized into vascular resection and non-vascular resection cohorts.
Trial design
Cohort
Retrospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionThis is an observational study. No intervention is assigned.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Complications Grade II or Higher (Clavien-Dindo ≥ II)
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)
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
Perioperative Mortality
Death occurring within 30 days after surgery or during the index hospitalization, whichever occurs later.
Length of Postoperative Hospital Stay
Number of days from the date of surgery to hospital discharge.
Intraoperative Blood Loss
Estimated blood loss recorded in the operative report, measured in milliliters.
Disease-Free Survival (DFS)
Time from surgery to tumor recurrence, metastasis, death from any cause, or last follow-up, whichever occurs first.
Locations
Sponsors and contacts
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Yongjun Chen
Lead sponsor
Tongji Hospital
Sponsor institution
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