This is a prospective, multicenter, single-arm study investigating the efficacy and safety of preoperative right hepatic artery embolization (PHAE) followed by surgical resection in patients with locally advanced Bismuth IIIb or IV perihilar cholangiocarcinoma (PHCC) involving the right hepatic artery. The standard treatment for such cases is often considered unresectable due to the high risk of hepatic ischemia after arterial resection without reconstruction. This study proposes a strategy: preoperative embolization of the tumor-involved right hepatic artery to stimulate the development of collateral arterial circulation (e.g., from the right inferior phrenic artery), enabling subsequent radical resection of the right hepatic artery without reconstruction. The primary objective is to evaluate the 1-year overall survival rate. Secondary objectives include surgical conversion rate, R0 resection rate, 1-year/3-year recurrence-free survival, 3-year overall survival rate and safety assessment. A total of 33 participants will be enrolled across multiple centers in China.
Signed informed consent.
Age 18-80 years.
Clinical diagnosis of Bismuth IIIb or IV perihilar cholangiocarcinoma, deemed suitable for radical resection via left hepatectomy or left trisectionectomy.
Imaging (CTA/MRA) confirms tumor invasion of the right hepatic artery (RHA) that is assessed as "unable to be safely reconstructed after resection" (e.g., involvement of RHA branches or requiring vascular graft for reconstruction).
Evidence of distant metastasis (M1).
History of other malignancies within the past 5 years (except cured basal cell carcinoma or cervical carcinoma in situ).
Severe cardiac, pulmonary, renal, or cerebrovascular disease as specified in the protocol (e.g., recent myocardial infarction, severe COPD, chronic renal failure stage ≥ III).
Uncontrolled active infection or diabetes.
Single group
Preoperative Right Hepatic Artery Embolization
Procedure/SurgeryParticipants receive preoperative selective embolization of the tumor-involved right hepatic artery, followed 2-4 weeks later by radical left hepatectomy or left trisectionectomy with resection of the involved artery without reconstruction.
1-Year Overall Survival
The proportion of patients alive at 1 year after the radical surgery date. Overall survival is defined as the time from surgery to death from any cause.
Surgical Conversion Rate
The proportion of enrolled patients who successfully undergo radical resection.
R0 Rate
The proportion of resected patients achieving microscopically negative cut margins at the axial and radial of bile duct tumor.
1-Year and 3-Year Recurrence-Free Survival Rate
The proportion of patients alive and free of tumor recurrence at 1 and 3 years after surgery. Recurrence-free survival is defined as the time from surgery to the first documented recurrence or death from any cause.
3-Year Overall Survival
The proportion of patients alive at 3 years after the radical surgery date.
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