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Completed

NCT Number: NCT01267669

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

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.

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Key information

Conditions

Acute Bleeding Esophageal Varices Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110 002, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Somatostatin

Drug

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

Other names: Somatosan, Somastin

Placebo

Drug

Emergency EVL plus placebo infusion for 5 days

Primary outcomes

  1. 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

  1. In-hospital mortality

    Time frame: During the same admission

    Death during the same admission to the hospital

  2. Transfusion requirement

    Time frame: During hospital stay

    Amount of packed cell or FFP infusions received during the hospital stay

  3. ICU stay in days

    Time frame: During the hospital stay

    Number of dys the patient spent in ICU

  4. Drug-related adverse effects

    Time frame: 5 days

    Adverse effects due to somatostatin or placebo infusion

Sponsors and collaborators

Lead sponsor

Govind Ballabh Pant Hospital

Other Gov

Registry information

Official study title

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

Acronym: AVB-EVL+S

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 28, 2010
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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