Cholangiocarcinoma, HilarNCT07311798
Impact of Vascular Resection on Survival and Postoperative Outcomes in Patients With Hilar Cholangiocarcinoma: A Retrospective Study
An observational study of Cholangiocarcinoma, Hilar, run by Yongjun Chen.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangiocarcinoma, Hilar
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this 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.
- Conditions
- Cholangiocarcinoma, Hilar
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is an observational study. No intervention is assigned.
| Study group | Role | What they receive |
|---|---|---|
| Vascular Resection Group | Patients with hilar cholangiocarcinoma who underwent curative-intent surgery with concomitant vascular resection, including portal vein and/or hepatic artery resection. Receives: Other: No Intervention: Observational Cohort | |
| Non-Vascular Resection Group | Patients with hilar cholangiocarcinoma who underwent curative-intent surgery without vascular resection. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From surgery to death or last follow-up (up to 5 years)
Secondary outcomes (4)
Perioperative Mortality
Death occurring within 30 days after surgery or during the index hospitalization, whichever occurs later.
Measured: 30 days after surgery or during hospitalization
Length of Postoperative Hospital Stay
Number of days from the date of surgery to hospital discharge.
Measured: 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.
Measured: During surgery
Disease-Free Survival (DFS)
Time from surgery to tumor recurrence, metastasis, death from any cause, or last follow-up, whichever occurs first.
Measured: From surgery to tumor recurrence, metastasis, death, or last follow-up (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma, HilarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongjun Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongjun Chen, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311798
- Sponsor's protocol ID
- BTC-002
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vascular Resection on Survival and Postoperative Outcomes in Patients With Hilar Cholangiocarcinoma: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07311798
- Acronym / sponsor ID
- BTC-002
- Conditions
- Cholangiocarcinoma, Hilar
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yongjun ChenUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular Resection Group | – | Other: No Intervention: Observational CohortPatients with hilar cholangiocarcinoma who underwent curative-intent surgery with concomitant vascular resection, including portal vein and/or hepatic artery resection. |
| Non-Vascular Resection Group | – | Other: No Intervention: Observational CohortPatients with hilar cholangiocarcinoma who underwent curative-intent surgery without vascular resection. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThis is an observational study. No intervention is assigned. | Other | Non-Vascular Resection Group, Vascular Resection Group |
Primary outcome
Postoperative Complications Grade II or Higher (Clavien-Dindo ≥ II)
Time frame: Within 30 days after surgery
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 frame: From surgery to death or last follow-up (up to 5 years)
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, Hilar, run by Yongjun Chen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complications Grade II or Higher (Clavien-Dindo ≥ II) (time frame: Within 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.