Radioactive stent insertion for inoperable hilar cholangiocarcinoma: a prospective randomized controlled trial.

Introduction: Hilar cholangiocarcinoma (HC) is the leading cause of hilar biliary obstruction. Radioactive stent insertion has been utilized extensively for inoperable HC patients.

Aim: To assess the relative clinical outcomes of inoperable HC patients who underwent either normal or radioactive stent insertion.

Material And Methods: This single-center, prospective, randomized, open-label study enrolled 90 inoperable HC patients from April 2021 to March 2022 and randomly assigned them to normal or radioactive stent groups (n = 45/group), with clinical data then being compared between these groups.

Results: Technical success rates in the normal and radioactive stent insertion groups were 93.3% and 97.9%, respectively (p = 1.000), and clinical success rates were similarly consistent in both groups (95.3% vs. 97.7%, p = 0.983). Individuals in the radioactive stent group exhibited significantly longer median stent patency as compared to the normal stent group (195 days vs. 115 days, p < 0.001), and median overall survival (OS) was also significantly increased in the normal stent group (242 days vs. 125 days, p = 0.002). In the normal stent insertion group, 6 (14.3%) and 5 (11.9%) patients experienced early and late postoperative complications, respectively. Additionally, early and late postoperative complications impacted 7 (16.3%) and 8 (18.6%) patients in the radioactive stent insertion group, respectively. Complication rates were comparable in these 2 patient groups.

Conclusions: Radioactive stent insertion represents a safe and effective strategy for patients with inoperable HC, potentially contributing to prolonged stent patency and OS relative to normal stent insertion.