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Not yet recruiting NCT07311798

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

Observational Cholangiocarcinoma, Hilar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Cholangiocarcinoma, Hilar. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other No Intervention: Observational Cohort
    This is an observational study. No intervention is assigned.

Primary outcome measures

  • Postoperative Complications Grade II or Higher (Clavien-Dindo ≥ II) [Time frame: Within 30 days after surgery]
  • Overall Survival (OS) [Time frame: From surgery to death or last follow-up (up to 5 years)]
Secondary outcome measures (4)
  • Perioperative Mortality [Time frame: 30 days after surgery or during hospitalization]
  • Length of Postoperative Hospital Stay [Time frame: From the date of surgery to hospital discharge, assessed up to 90 days.]
  • Intraoperative Blood Loss [Time frame: During surgery]
  • Disease-Free Survival (DFS) [Time frame: From surgery to tumor recurrence, metastasis, death, or last follow-up (up to 5 years)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07311798 · BTC-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗