Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma

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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* 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).
* Portal vein on the side of the future liver remnant is not invaded or is reconstructable.
* ECOG performance status 0-1.
* Child-Pugh score ≤ 7 (Class A or B).
* Adequate organ function (bone marrow, liver, kidney) as per protocol-defined laboratory values.
* Expected survival ≥ 12 weeks.

Exclusion Criteria:

* 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.
* Pregnancy or lactation.
* Allergy to iodinated contrast media.
* Postoperative pathology confirms non-cholangiocarcinoma.

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