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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYongjun Chen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    This is an observational study. No intervention is assigned.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Vascular Resection Group1 intervention
Group B: Non-Vascular Resection Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 30 days after surgery
2

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.

Time frame
From surgery to death or last follow-up (up to 5 years)

Secondary outcomes

1

Perioperative Mortality

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

Time frame
30 days after surgery or during hospitalization
2

Length of Postoperative Hospital Stay

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

Time frame
From the date of surgery to hospital discharge, assessed up to 90 days.
3

Intraoperative Blood Loss

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

Time frame
During surgery
4

Disease-Free Survival (DFS)

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yongjun Chen

Lead sponsor

Tongji Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: