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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholangiocarcinoma, Hilar
• Intervention / Treatment: Other: No Intervention: Observational Cohort

• Study Type: Observational
• Enrollment (Estimated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vascular Resection Group; Patients with hilar cholangiocarcinoma who underwent curative-intent surgery with concomitant vascular resection, including portal vein and/or hepatic artery resection.	Other: No Intervention: Observational Cohort; This is an observational study. No intervention is assigned.
Non-Vascular Resection Group; Patients with hilar cholangiocarcinoma who underwent curative-intent surgery without vascular resection.	Other: No Intervention: Observational Cohort; This is an observational study. No intervention is assigned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 30 days after surgery
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.	From surgery to death or last follow-up (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Mortality	Death occurring within 30 days after surgery or during the index hospitalization, whichever occurs later.	30 days after surgery or during hospitalization
Length of Postoperative Hospital Stay	Number of days from the date of surgery to hospital discharge.	From the date of surgery to hospital discharge, assessed up to 90 days.
Intraoperative Blood Loss	Estimated blood loss recorded in the operative report, measured in milliliters.	During surgery
Disease-Free Survival (DFS)	Time from surgery to tumor recurrence, metastasis, death from any cause, or last follow-up, whichever occurs first.	From surgery to tumor recurrence, metastasis, death, or last follow-up (up to 5 years)

Collaborators and Investigators

• Sponsor: Yongjun Chen

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: BTC-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No