Randomized trial of portacaval shunt, stapling transection and endoscopic sclerotherapy in uncontrolled variceal bleeding.

Seventy consecutive cirrhotic patients with persistent or recurrent variceal bleeding were included in a clinical trial to compare the efficacy and safety of portacaval shunt (PCS) and stapler transection (ST) in patients with low surgical risk, and of stapler transection and endoscopic sclerotherapy (ES) in patients with high surgical risk. To classify the patients into low- and high-risk groups a new scoring system was used, based on an analysis of factors influencing operative mortality in an earlier series of emergency portacaval shunt. Thirty-eight low-risk patients were randomly allocated for treatment with portacaval shunt (19 patients) or stapler transection (19 patients), and 32 high-risk patients for stapler transection (17 patients) or ES (15 patients). The operative mortality of patients treated by PCS was close to that expected according to retrospective data, this indicating that the proposed scoring system is highly discriminant. In low-risk patients, portacaval shunt evidenced greater haemostatic efficacy and fewer complications than stapler transection. However, hepatic encephalopathy during follow-up was more frequent in the portacaval shunt group and there were no significant differences in operative mortality and long-term survival between the two groups. In high-risk patients, stapler transection and sclerotherapy had a similar haemostatic efficacy, operative mortality and long-term survival. However, sclerotherapy occasioned fewer complications than stapler transection. Our results motivate us to recommend stapler transection for low-risk patients and to consider sclerotherapy as an alternative for high-risk patients in the emergency treatment of uncontrolled variceal bleeding.

RCT Entities:   Population Interventions Outcomes