Partial splenic embolization combined with endoscopic therapies and vasoconstrictive drugs reduces rebleeding in cirrhosis patients with acute variceal bleeding and hypersplenism: a multicenter randomized controlled trial

Background This study aimed to compare the efficacy of partial splenic embolization (PSE) combined with endoscopic therapy and endoscopic therapy alone in cirrhosis patients with acute variceal bleeding (AVB) and hypersplenism. Methods Cirrhosis patients with AVB who visited three hospitals from June 2016 to June 2022 were prospectively enrolled and randomly allocated to either the endoscopic therapy combined with PSE group (EP group) or the endoscopic intervention group (E group) in a 1:1 ratio. The primary endpoint of the study was re-bleeding of varices during follow-up, and the secondary endpoints were the recurrence of varices, death, and adverse events. Results One hundred and fourteen patients were prospectively included, of whom 110 completed the trial. The risk of variceal re-bleeding (19.3% vs. 40.4% (23/57), p = 0.013) and variceal recurrence (28.1% vs. 63.2%, p < 0.001) five years after treatment was significantly lower in the EP group than in the E group, and the EP treatment was the only significant independent risk factor affecting variceal re-bleeding and variceal recurrence in patients. The mortality rate was comparable between the EP and E groups. Peripheral blood counts and liver function all improved significantly in the EP group compared to the E group during the follow-up ( p < 0.05). Conclusions The rates of variceal re-bleeding and recurrence were significantly lower in cirrhosis patients with AVB and hypersplenism after combined endoscopic and PSE treatment compared to those who were provided endoscopic treatment only. The peripheral blood counts and liver function were also improved significantly in EP group (NCT02778425).