A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Govind Ballabh Pant Hospital
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Treatment failure
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of portal hypertension
- •Having hematemesis and/or melena within 24 hour prior to admission
- •Source of bleeding should be esophageal varices
Exclusion Criteria
- •Non-cirrhotic cause of portal hypertension
- •Age <12 or >75 years
- •Hepatic encephalopathy grade 3 or 4
- •Renal failure with serum creatinine >2 mg/dL
- •Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
- •Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding
- •Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital
- •Patients with history of surgery for portal hypertension or TIPS
- •Concomitant severe cardio-pulmonary disease
- •Concomitant malignancy
- •HVPG not possible within 24 hrs of presentation
- •Patients refusing to participate in the study.
Arms & Interventions
EVL plus Somatostatin
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
Intervention: Somatostatin (Drug)
EVL plus Placebo
Emergency EVL plus placebo infusion for 5 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Treatment failure
Time Frame: 5 days
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.
Secondary Outcomes
- In-hospital mortality(During the same admission)
- Transfusion requirement(During hospital stay)
- ICU stay in days(During the hospital stay)
- Drug-related adverse effects(5 days)