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

This study has been completed.
Information provided by:
Govind Ballabh Pant Hospital Identifier:
First received: December 27, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

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 Intervention
Acute Bleeding Esophageal Varices Portal Hypertension Cirrhosis Drug: Somatostatin Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • In-hospital mortality [ Time Frame: During the same admission ]
    Death during the same admission to the hospital

  • Transfusion requirement [ Time Frame: During hospital stay ]
    Amount of packed cell or FFP infusions received during the hospital stay

  • ICU stay in days [ Time Frame: During the hospital stay ]
    Number of dys the patient spent in ICU

  • Drug-related adverse effects [ Time Frame: 5 days ]
    Adverse effects due to somatostatin or placebo infusion

Enrollment: 61
Study Start Date: November 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   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.
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Please refer to this study by its identifier: NCT01267669

Department of Gastroenterology, G B Pant Hospital
New Delhi, Delhi, India, 110 002
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Principal Investigator: Shiv K Sarin, MD, DM G B Pant Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr S K Sarin, Department of Gastroenterology, G B Pant Hospital, New Delhi, India Identifier: NCT01267669     History of Changes
Other Study ID Numbers: 2005-PHT-01
Study First Received: December 27, 2010
Last Updated: December 27, 2010

Keywords provided by Govind Ballabh Pant Hospital:
Variceal bleeding
Endoscopic therapy
Band ligation
Vasoactive drugs

Additional relevant MeSH terms:
Hypertension, Portal
Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on August 16, 2017