Ashish Kumar1, Sanjeev K Jha2, Vibhu V Mittal2, Praveen Sharma1, Barjesh C Sharma2, Shiv K Sarin3. 1. Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), New Delhi, India ; Department of Gastroenterology, G B Pant Hospital, University of Delhi, New Delhi, India ; Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi, India. 2. Department of Gastroenterology, G B Pant Hospital, University of Delhi, New Delhi, India. 3. Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS), New Delhi, India ; Department of Gastroenterology, G B Pant Hospital, University of Delhi, New Delhi, India.
Abstract
BACKGROUND: Efficacy of endoscopic sclerotherapy in controlling acute variceal bleeding is significantly improved when vasoactive drug is added. Endoscopic variceal ligation (EVL) is superior to sclerotherapy. Whether efficacy of EVL will also improve with addition of somatostatin is not known. We compared EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding. METHODS:Consecutive cirrhotic patients with acute esophageal variceal bleeding were enrolled. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 h after start of therapy, or a 3 gm drop in Hb, or death. RESULTS:61 patients were enrolled (EVL plus somatostatin group, n = 31 and EVL plus placebo group, n = 30). The baseline characteristics were similar. Within the initial 5-day period, the frequency of treatment failure was similar in both the groups (EVL plus somatostatin group 8/31 [26%] versus EVL plus placebo group 7/30 [23%]; P = 1.000). The mortality was also similar in the two groups (3/31 [10%] vs. 3/30 [10%]; P = 1.000). Baseline HVPG ≥19 mm Hg and active bleeding at index endoscopy were independent predictors of treatment failure. CONCLUSIONS: Addition of somatostatin infusion to EVL therapy does not offer any advantage in control of acute variceal bleeding or reducing mortality. The reason for this may be its failure to maintain sustained reduction in portal pressure for five days. Active bleeding at index endoscopy and high baseline HVPG should help choose early alternative treatment options. Trial registered with ClincalTrials.gov vide NCT01267669.
RCT Entities:
BACKGROUND: Efficacy of endoscopic sclerotherapy in controlling acute variceal bleeding is significantly improved when vasoactive drug is added. Endoscopic variceal ligation (EVL) is superior to sclerotherapy. Whether efficacy of EVL will also improve with addition of somatostatin is not known. We compared EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding. METHODS: Consecutive cirrhotic patients with acute esophageal variceal bleeding were enrolled. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 h after start of therapy, or a 3 gm drop in Hb, or death. RESULTS: 61 patients were enrolled (EVL plus somatostatin group, n = 31 and EVL plus placebo group, n = 30). The baseline characteristics were similar. Within the initial 5-day period, the frequency of treatment failure was similar in both the groups (EVL plus somatostatin group 8/31 [26%] versus EVL plus placebo group 7/30 [23%]; P = 1.000). The mortality was also similar in the two groups (3/31 [10%] vs. 3/30 [10%]; P = 1.000). Baseline HVPG ≥19 mm Hg and active bleeding at index endoscopy were independent predictors of treatment failure. CONCLUSIONS: Addition of somatostatin infusion to EVL therapy does not offer any advantage in control of acute variceal bleeding or reducing mortality. The reason for this may be its failure to maintain sustained reduction in portal pressure for five days. Active bleeding at index endoscopy and high baseline HVPG should help choose early alternative treatment options. Trial registered with ClincalTrials.gov vide NCT01267669.
Authors: Waqar Qureshi; Douglas G Adler; Raquel Davila; James Egan; William Hirota; Jonathan Leighton; Elizabeth Rajan; Marc J Zuckerman; Robert Fanelli; Jo Wheeler-Harbaugh; Todd H Baron; Douglas O Faigel Journal: Gastrointest Endosc Date: 2005-11 Impact factor: 9.427
Authors: A Escorsell ; J C Bandi; V Andreu; E Moitinho; J C García-Pagán; J Bosch; J Rodés Journal: Gastroenterology Date: 2001-01 Impact factor: 22.682
Authors: Juan Carlos García-Pagán; Karel Caca; Christophe Bureau; Wim Laleman; Beate Appenrodt; Angelo Luca; Juan G Abraldes; Frederik Nevens; Jean Pierre Vinel; Joachim Mössner; Jaime Bosch Journal: N Engl J Med Date: 2010-06-24 Impact factor: 91.245
Authors: Danielle Roberts; Lawrence Mj Best; Suzanne C Freeman; Alex J Sutton; Nicola J Cooper; Sivapatham Arunan; Tanjia Begum; Norman R Williams; Dana Walshaw; Elisabeth Jane Milne; Maxine Tapp; Mario Csenar; Chavdar S Pavlov; Brian R Davidson; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2021-04-10