BACKGROUND:Gastroesophageal variceal bleeding is a common complication of portal hypertension. Current guidelines recommend thorn-blockers for primary prophylaxis. However, evidence suggests that endoscopic variceal ligation (EVL) reduce bleeding episodes. AIMS: To compare endoscopic EVL with propranolol (PPL) for primary prophylaxis of variceal bleeding. METHODS: We conducted a randomized controlled trial. Over a 9-year period, 75 patients with cirrhosis and high-risk esophageal varices (HREV) were recruited and allocated to EVL (n=39) or PPL (n=36). Primary outcome was variceal bleeding. Secondary outcomes were survival, source of bleeding and serious adverse events. Analyses were made by intention-to-treat. RESULTS: Baseline characteristics were similar. Medium follow-up was 1647+/-1096 days. complete follow-up was achieved in 85% of patients. Variceal bleeding occurred in 12% of EVL and in 25% of PPL group (p=0.17). The actuarial risks of bleeding after 2 years were similar in both groups. Overall mortality was 51% in EVL and 33% in PPL group (p=0.17). Patients in the EVL group showed a lower rate of esophageal variceal bleeding (5.1% v/s 25%, p=0.027) and a higher rate of subcardial variceal bleeding compared with PPL group (7.7% v/s 0%, p=0.027). Serious adverse events related to EVL occurred in 2 patients, including 1 death. CONCLUSIONS: The present study supports that PPL should be considered the first choice in primary prophylaxis of variceal bleeding offering similar effects and lower severe adverse events compared with EVL.
RCT Entities:
BACKGROUND:Gastroesophageal variceal bleeding is a common complication of portal hypertension. Current guidelines recommend thorn-blockers for primary prophylaxis. However, evidence suggests that endoscopic variceal ligation (EVL) reduce bleeding episodes. AIMS: To compare endoscopic EVL with propranolol (PPL) for primary prophylaxis of variceal bleeding. METHODS: We conducted a randomized controlled trial. Over a 9-year period, 75 patients with cirrhosis and high-risk esophageal varices (HREV) were recruited and allocated to EVL (n=39) or PPL (n=36). Primary outcome was variceal bleeding. Secondary outcomes were survival, source of bleeding and serious adverse events. Analyses were made by intention-to-treat. RESULTS: Baseline characteristics were similar. Medium follow-up was 1647+/-1096 days. complete follow-up was achieved in 85% of patients. Variceal bleeding occurred in 12% of EVL and in 25% of PPL group (p=0.17). The actuarial risks of bleeding after 2 years were similar in both groups. Overall mortality was 51% in EVL and 33% in PPL group (p=0.17). Patients in the EVL group showed a lower rate of esophageal variceal bleeding (5.1% v/s 25%, p=0.027) and a higher rate of subcardial variceal bleeding compared with PPL group (7.7% v/s 0%, p=0.027). Serious adverse events related to EVL occurred in 2 patients, including 1 death. CONCLUSIONS: The present study supports that PPL should be considered the first choice in primary prophylaxis of variceal bleeding offering similar effects and lower severe adverse events compared with EVL.
Authors: Michael B Streiff; Paula L Bockenstedt; Spero R Cataland; Carolyn Chesney; Charles Eby; John Fanikos; Patrick F Fogarty; Shuwei Gao; Julio Garcia-Aguilar; Samuel Z Goldhaber; Hani Hassoun; Paul Hendrie; Bjorn Holmstrom; Kimberly A Jones; Nicole Kuderer; Jason T Lee; Michael M Millenson; Anne T Neff; Thomas L Ortel; Judy L Smith; Gary C Yee; Anaadriana Zakarija Journal: J Natl Compr Canc Netw Date: 2011-07-01 Impact factor: 11.908
Authors: Davide Roccarina; Lawrence Mj Best; Suzanne C Freeman; Danielle Roberts; Nicola J Cooper; Alex J Sutton; Amine Benmassaoud; Maria Corina Plaz Torres; Laura Iogna Prat; Mario Csenar; Sivapatham Arunan; Tanjia Begum; Elisabeth Jane Milne; Maxine Tapp; Chavdar S Pavlov; Brian R Davidson; Emmanuel Tsochatzis; Norman R Williams; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2021-04-06
Authors: Mariusz Rosołowski; Marek Hartleb; Tomasz Marek; Janusz Milewski; Krzysztof Linke; Grzegorz Wallner; Andrzej Dąbrowski; Grażyna Rydzewska Journal: Prz Gastroenterol Date: 2014-05-05