Volume-Restricted Resection for Perihilar Cholangiocarcinoma
ConditionCholangiocarcinoma, Hilar
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYongjun Chen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From the date of surgery/treatment until death or study termination, approximately 5 years.Secondary outcomes
1
Progression-free survival
From the date the patient begins treatment to the date of disease progression or death, whichever occurs first.
Time frame
Disease progression/death2
R0 resection rate
The percentage of subjects achieving R0 resection.
Time frame
Within 7 days after surgery(pathology report)3
90-day mortality
The percentage of patients who died within 90 days among all patients.
Time frame
90 days after the surgery4
Health-Related Quality of Life (HRQoL)
HRQoL will be assessed during treatment follow-up using the EORTC QLQ-C30 questionnaire.
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yongjun Chen
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: