Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL. Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding. Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. 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 hour after start of therapy or death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
Emergency EVL plus placebo infusion for 5 days
Department of Gastroenterology, G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India
Treatment failure
The primary endpoint was treatment failure, defined as the occurrence of any of the following within a period of 120 h (5 days) from the time of admission: (i) Fresh hematemesis ≥2 hr after EVL; or (ii) Death within 5 days.
Time frame: 5 days
In-hospital mortality
Death during the same admission to the hospital
Time frame: During the same admission
Transfusion requirement
Amount of packed cell or FFP infusions received during the hospital stay
Time frame: During hospital stay
ICU stay in days
Number of dys the patient spent in ICU
Time frame: During the hospital stay
Drug-related adverse effects
Adverse effects due to somatostatin or placebo infusion
Time frame: 5 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.