AVB-EVL+S: A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding

Sponsor

Govind Ballabh Pant Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01267669

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Bleeding Esophageal Varices Portal Hypertension Cirrhosis	Drug: Somatostatin Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EVL plus Somatostatin Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days	Drug: Somatostatin Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days Other Names: Somatosan Somastin
Placebo Comparator: EVL plus Placebo Emergency EVL plus placebo infusion for 5 days	Drug: Placebo Emergency EVL plus placebo infusion for 5 days

Arm

Intervention/Treatment

Experimental: EVL plus Somatostatin

Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days

Drug: Somatostatin

Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days

Other Names:

Somatosan

Somastin

Placebo Comparator: EVL plus Placebo

Emergency EVL plus placebo infusion for 5 days

Drug: Placebo

Emergency EVL plus placebo infusion for 5 days

Outcome Measures

Primary Outcome Measures

Treatment failure [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.