TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort
NCT07454486
Adenocarcinoma, Biliary Tract Cancer (BTC)
Aarhus, Denmark
View Trial DetailsNCT Number: NCT07149558
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.
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Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Disease progression/death
From the date the patient begins treatment to the date of disease progression or death, whichever occurs first.
Time frame: Within 7 days after surgery(pathology report)
The percentage of subjects achieving R0 resection.
Time frame: 90 days after the surgery
The percentage of patients who died within 90 days among all patients.
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.
HRQoL will be assessed during treatment follow-up using the EORTC QLQ-C30 questionnaire.
Time frame: Within 90 days after the operation
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.
Contact information is provided by the study sponsor or research team.
Yongjun Chen
Other
Volume-Restricted Liver Resections for Perihilar Cholangiocarcinoma With Insufficient Future Liver Remnant Volume: A Prospective, Multicenter, Real-World Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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