title: Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial.
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.
authors.affiliation: 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.
authors.forename: Ashish
authors.initials: A
authors.lastname: Kumar
authors.affiliation: Department of Gastroenterology, G B Pant Hospital, University of Delhi, New Delhi, India.
authors.forename: Sanjeev K
authors.initials: SK
authors.lastname: Jha
authors.affiliation: Department of Gastroenterology, G B Pant Hospital, University of Delhi, New Delhi, India.
authors.forename: Vibhu V
authors.initials: VV
authors.lastname: Mittal
authors.affiliation: 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.
authors.forename: Praveen
authors.initials: P
authors.lastname: Sharma
authors.affiliation: Department of Gastroenterology, G B Pant Hospital, University of Delhi, New Delhi, India.
authors.forename: Barjesh C
authors.initials: BC
authors.lastname: Sharma
authors.affiliation: 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.
authors.forename: Shiv K
authors.initials: SK
authors.lastname: Sarin
keywords: AVB, Acute variceal bleeding; Band ligation; CTP, Child Turcotte Pugh; EVL, Endoscopic variceal ligation; Endoscopic therapy; FFP, Fresh frozen plasma; HVPG, Hepatic venous pressure gradient; ICU, Intensive care unit; Octreotide; ROC, Receiver operating characteristics; Terlipressin; Variceal bleeding