A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding

Study Overview
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Brief Summary
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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.

Official Title
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A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding

Conditions
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Acute Bleeding Esophageal Varices, Portal Hypertension, Cirrhosis

Intervention / Treatment
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* Drug: Somatostatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVL plus Somatostatin<br>Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days | Drug: Somatostatin<br>* Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days<br>* Other names: Somastin;|
| Placebo Comparator: EVL plus Placebo<br>Emergency EVL plus placebo infusion for 5 days | Drug: Placebo<br>* Emergency EVL plus placebo infusion for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Death during the same admission to the hospital | During the same admission | 
| Transfusion requirement | Amount of packed cell or FFP infusions received during the hospital stay | During hospital stay | 
| ICU stay in days | Number of dys the patient spent in ICU | During the hospital stay | 
| Drug-related adverse effects | Adverse effects due to somatostatin or placebo infusion | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Variceal bleeding, Endoscopic therapy, Band ligation, Somatostatin, Vasoactive drugs, Octreotide