Cholangiocarcinoma, HilarNCT07149558
Volume-Restricted Resection for Perihilar Cholangiocarcinoma
An observational study of Cholangiocarcinoma, Hilar, run by Yongjun Chen.
Trial summary
The goal of this observational study is to learn about the safety and long-term outcomes of volume-restricted liver resection in patients with perihilar cholangiocarcinoma (pCCA) who have an insufficient future liver remnant (FLR). 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
- Jan 2026to Jan 2034
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with perihilar cholangiocarcinoma and insufficient future liver remnant will be consecutively enrolled according to the inclusion and exclusion criteria. In addition, to better characterize the long-term survival of pCCA patients after surgical treatment, data from patients undergoing standard radical resection for pCCA will also be collected.
Who may be able to join
- Patients with pathologically confirmed hilar cholangiocarcinoma, or those with a high index of clinical suspicion for hilar bile duct malignancy despite the lack of histological confirmation.
- Patients who are able to understand and cooperate with this study.
- Patients who are able to provide and sign the written informed consent form before undergoing any screening procedures related to the study.
Who cannot join
- Patients with preoperatively or intraoperatively confirmed distant metastasis, including peritoneal dissemination, distant lymph node metastasis, hepatic or other organ metastasis.
- Patients who underwent palliative surgery only.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Volume-Restricted Liver Resections for Perihilar Cholangiocarcinoma With Insufficient Future Liver Remnant Volume: A Prospective, Multicenter, Real-World Study
The goal of this observational study is to learn about the safety and long-term outcomes of volume-restricted liver resection in patients with perihilar cholangiocarcinoma (pCCA) who have an insufficient future liver remnant (FLR). The main question it aims to answer is:
Does volume-restricted liver resection improve surgical safety and long-term survival compared with standard treatment in pCCA patients with insufficient FLR?
Participants with insufficient FLR who undergo volume-restricted liver resection or receive non-surgical treatment as part of their routine medical care will be followed for survival, postoperative complications, and other clinical outcomes. Data from patients with sufficient FLR undergoing standard radical resection will also be collected for comparison.
Read the detailed description
Perihilar cholangiocarcinoma (pCCA) is a highly malignant tumor arising at the confluence of the right and left hepatic bile ducts. Its deep anatomical location and proximity to critical vascular structures render curative resection technically challenging and associated with substantial surgical risk. Surgical resection remains the only potentially curative treatment offering long-term survival. However, in some patients, an insufficient future liver remnant (FLR) precludes extensive hepatectomy, as it markedly increases the risk of postoperative liver failure and mortality, thereby limiting resectability and adversely affecting prognosis.
In recent years, volume-restricted liver resection has attracted growing interest. By ensuring negative bile duct margins while preserving as much functional liver parenchyma as possible, this approach may reduce the incidence of postoperative liver failure and improve both overall survival and quality of life. Nevertheless, prospective, multicenter, real-world evidence on the safety and efficacy of volume-restricted liver resection in pCCA patients with insufficient FLR remains scarce.
Against this background, the present study will target pCCA patients with insufficient FLR, implementing surgical strategies tailored to tumor extent and clinical presentation. These include perihilar resection, segment IVb resection, caudate-lobe-based resection (Taj Mahal procedure: resection of S1 + S4b + S5), and central hepatectomy (resection of S1 + S4 + S5 + S8). Outcomes will be compared with those of patients receiving non-surgical multimodal therapy, as well as with patients with sufficient FLR undergoing standard radical resection. By leveraging prospective, multicenter, real-world data, this study aims to evaluate the role of volume-restricted liver resection in improving surgical safety, reducing postoperative complications, and enhancing long-term survival, thereby providing evidence to refine surgical strategies for pCCA.
- Conditions
- Cholangiocarcinoma, Hilar
- Medical subject headings
- Klatskin Tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The period from the time when the patient was diagnosed with the disease or began receiving corresponding treatment until his or her death due to any cause.
Measured: From the date of surgery/treatment until death or study termination, approximately 5 years.
Secondary outcomes (5)
Progression-free survival
From the date the patient begins treatment to the date of disease progression or death, whichever occurs first.
Measured: Disease progression/death
R0 resection rate
The percentage of subjects achieving R0 resection.
Measured: Within 7 days after surgery(pathology report)
90-day mortality
The percentage of patients who died within 90 days among all patients.
Measured: 90 days after the surgery
Health-Related Quality of Life (HRQoL)
HRQoL will be assessed during treatment follow-up using the EORTC QLQ-C30 questionnaire.
Measured: Surgical patients will receive monthly safety follow-ups (30 ± 7 days) for 3 months after discharge. All patients will have telephone survival/recurrence follow-ups every 2 months (60 ± 14 days) until death, loss to follow-up, or study end.
Incidence of postoperative complications
Defined as the percentage of patients who developed complications within 90 days after the operation among all included patients. Postoperative complications include bleeding, biliary fistula, abdominal cavity, liver failure, systemic inflammatory response syndrome (SIRS), gastrointestinal dysfunction, etc.
Measured: Within 90 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2034 (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
- Prospective
- 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
- NCT07149558
- Sponsor's protocol ID
- TJ-IRB202507012
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume-Restricted Liver Resections for Perihilar Cholangiocarcinoma With Insufficient Future Liver Remnant Volume: A Prospective, Multicenter, Real-World Study
- ClinicalTrials.gov ID
- NCT07149558
- Acronym / sponsor ID
- TJ-IRB202507012
- Conditions
- Cholangiocarcinoma, Hilar
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yongjun ChenUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 2 Sep 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.
The goal of this observational study is to learn about the safety and long-term outcomes of volume-restricted liver resection in patients with perihilar cholangiocarcinoma (pCCA) who have an insufficient future liver remnant (FLR). The main question it aims to answer is:
Does volume-restricted liver resection improve surgical safety and long-term survival compared with standard treatment in pCCA patients with insufficient FLR?
Participants with insufficient FLR who undergo volume-restricted liver resection or receive non-surgical treatment as part of their routine medical care will be followed for survival, postoperative complications, and other clinical outcomes. Data from patients with sufficient FLR undergoing standard radical resection will also be collected for comparison.
Detailed description
Perihilar cholangiocarcinoma (pCCA) is a highly malignant tumor arising at the confluence of the right and left hepatic bile ducts. Its deep anatomical location and proximity to critical vascular structures render curative resection technically challenging and associated with substantial surgical risk. Surgical resection remains the only potentially curative treatment offering long-term survival. However, in some patients, an insufficient future liver remnant (FLR) precludes extensive hepatectomy, as it markedly increases the risk of postoperative liver failure and mortality, thereby limiting resectability and adversely affecting prognosis.
In recent years, volume-restricted liver resection has attracted growing interest. By ensuring negative bile duct margins while preserving as much functional liver parenchyma as possible, this approach may reduce the incidence of postoperative liver failure and improve both overall survival and quality of life. Nevertheless, prospective, multicenter, real-world evidence on the safety and efficacy of volume-restricted liver resection in pCCA patients with insufficient FLR remains scarce.
Against this background, the present study will target pCCA patients with insufficient FLR, implementing surgical strategies tailored to tumor extent and clinical presentation. These include perihilar resection, segment IVb resection, caudate-lobe-based resection (Taj Mahal procedure: resection of S1 + S4b + S5), and central hepatectomy (resection of S1 + S4 + S5 + S8). Outcomes will be compared with those of patients receiving non-surgical multimodal therapy, as well as with patients with sufficient FLR undergoing standard radical resection. By leveraging prospective, multicenter, real-world data, this study aims to evaluate the role of volume-restricted liver resection in improving surgical safety, reducing postoperative complications, and enhancing long-term survival, thereby providing evidence to refine surgical strategies for pCCA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with perihilar cholangiocarcinoma and insufficient future liver remnant will be consecutively enrolled according to the inclusion and exclusion criteria. In addition, to better characterize the long-term survival of pCCA patients after surgical treatment, data from patients undergoing standard radical resection for pCCA will also be collected.
Key inclusion criteria (3 listed)
- Patients with pathologically confirmed hilar cholangiocarcinoma, or those with a high index of clinical suspicion for hilar bile duct malignancy despite the lack of histological confirmation.
- Patients who are able to understand and cooperate with this study.
- Patients who are able to provide and sign the written informed consent form before undergoing any screening procedures related to the study.
Key exclusion criteria (2 listed)
- Patients with preoperatively or intraoperatively confirmed distant metastasis, including peritoneal dissemination, distant lymph node metastasis, hepatic or other organ metastasis.
- Patients who underwent palliative surgery only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: From the date of surgery/treatment until death or study termination, approximately 5 years.
The period from the time when the patient was diagnosed with the disease or began receiving corresponding treatment until his or her death due to any cause.
5 secondary outcomes
Progression-free survival
Time frame: Disease progression/death
R0 resection rate
Time frame: Within 7 days after surgery(pathology report)
90-day mortality
Time frame: 90 days after the surgery
Health-Related Quality of Life (HRQoL)
Time frame: Surgical patients will receive monthly safety follow-ups (30 ± 7 days) for 3 months after discharge. All patients will have telephone survival/recurrence follow-ups every 2 months (60 ± 14 days) until death, loss to follow-up, or study end.
Incidence of postoperative complications
Time frame: Within 90 days after the operation
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 2 Sep 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.
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 2 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 2 Sep 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?
Contact Yongjun Chen, Ph.D. (+862783665315, yjchen@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the date of surgery/treatment until death or study termination, approximately 5 years.). 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 2 Sep 2025.