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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.
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01267669
First received: December 27, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Treatment failure [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Death during the same admission to the hospital

  • Transfusion requirement [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
    Amount of packed cell or FFP infusions received during the hospital stay

  • ICU stay in days [ Time Frame: During the hospital stay ] [ Designated as safety issue: No ]
    Number of dys the patient spent in ICU

  • Drug-related adverse effects [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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:
  • Somatostatin
  • 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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267669

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

No publications provided

Responsible Party: Dr S K Sarin, Department of Gastroenterology, G B Pant Hospital, New Delhi, India
ClinicalTrials.gov Identifier: NCT01267669     History of Changes
Other Study ID Numbers: 2005-PHT-01
Study First Received: December 27, 2010
Last Updated: December 27, 2010
Health Authority: India: Ministry of Health

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

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal and Gastric Varices
Hemorrhage
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Varicose Veins
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
 Digestive System Diseases
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013