A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding q,qq Ca `ndid Villanueva 1, * , Marta Piqueras 1 , Carles Aracil 1 , Cristina Go ´mez 1 , Josep M. Lo ´ pez-Balaguer 1 , Begon ˜ a Gonzalez 1 , Adolfo Gallego 1 , Xavier Torras 1 , Germa ` Soriano 1 , Sergio Sa ´inz 1 , Salvador Benito 2 , Joaquim Balanzo ´ 1 1 Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain 2 Intermediate Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain Background/ Aims: The currently recommended treatment for acute variceal bleeding is the association of vasoactive drugs and endoscopic therapy. However, which emergency endoscopic treatment combines better with drugs has not been clarified. This study compares the efficacy and safety of variceal ligation and sclerotherapy as emergency endoscopic treat- ment added to somatostatin. Methods: Patients admitted with acute gastrointestinal bleeding and with suspected cirrhosis received somatostatin infu- sion (for 5 days). Endoscopy was performed within 6 h and those with esophageal variceal bleeding were randomized to receive either sclerotherapy (N = 89) or ligation (N = 90). Results: Therapeutic failure occurred in 21 patients treated with sclerotherapy (24%) and in nine treated with ligation (10%) (RR = 2.4, 95% CI = 1.1–4.9). Failure to control bleeding occurred in 15% vs 4%, respectively (P = 0.02). Treat- ment group, shock and HVPG >16 mmHg were independent predictors of failure. Side-effects occurred in 28% of patients receiving sclerotherapy vs 14% with ligation (RR = 1.9, 95% CI = 1.1–3.5), being serious in 13% vs 4% (P = 0.04). Six- week survival probability without therapeutic failure was better with ligation (P = 0.01). Conclusions: The use of variceal ligation instead of sclerotherapy as emergency endoscopic therapy added to somatostat- in for the treatment of acute variceal bleeding significantly improves the efficacy and safety. Ó 2006 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved. Keywords: Cirrhosis; Portal hypertension; Esophageal variceal bleeding; Endoscopic therapy; Randomized controlled trial 1. Introduction Hemostatic treatment is essential in acute esophageal variceal bleeding, a medical emergency associated with relevant morbidity and mortality [1,2]. Available evi- dence suggests that emergency sclerotherapy (EST) and vasoactive drugs have a similar efficacy and survival [3,4]. However, EST is associated with more frequent serious adverse events [4]. By combining both therapies, the local hemostatic effect induced by endoscopic treat- ment on the varices is added to the portal hypotensive effect achieved with drugs. This combination is the ther- apy of choice currently recommended for acute variceal 0168-8278/$32.00 Ó 2006 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.jhep.2006.05.016 Received 6 December 2005; received in revised form 30 May 2006; accepted 31 May 2006; available online 28 June 2006 q This study has been supported in part by a grant from the Fundacio ´ Investigacio ´ Sant Pau and by a grant from the Instituto de Salud Carlos III (CO3/02). qq The authors who have taken part in this study declared that they have no relationship with the manufactures of the drugs involved either in the past or present and did not receive funding from the manufacturers to carry out their research. * Corresponding author. Tel.: +34 93 291 91 39; fax: +34 93 291 95 06. E-mail address: cvillanueva@santpau.es (C. Villanueva). Abbreviations: EST, emergency sclerotherapy; EVL, emergency variceal ligation; SMT, somatostatin; TIPS, transjugular intrahepatic portosystemic shunt; HVPG, hepatic venous pressure gradient; RR, relative risk; OR, odds ratio; CI, confidence interval; SD, standard deviation. www.elsevier.com/locate/jhep Journal of Hepatology 45 (2006) 560–567