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

NCT07311798 | Not Yet Recruiting

• 1 other identifier: BTC-002
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cholangiocarcinoma, Hilar

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (2)

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

Non-Vascular Resection Group

Patients with hilar cholangiocarcinoma who underwent curative-intent surgery without vascular resection.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

This is an observational study. No intervention is assigned.

Non-Vascular Resection Group; Vascular Resection Group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yongjun Chen: lead

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: December 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12