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

NCT01267669 | Completed

• 1 other identifier: 2005-PHT-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bleeding Esophageal Varices; Portal Hypertension; Cirrhosis

Keywords

Variceal bleeding; Endoscopic therapy; Band ligation; Somatostatin; Vasoactive drugs; Octreotide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• In-hospital mortality

  During the same admission

• Transfusion requirement

  During hospital stay

• ICU stay in days

  During the hospital stay

• Drug-related adverse effects

  5 days

Study Arms (2)

EVL plus Somatostatin

EXPERIMENTAL

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

Drug: Somatostatin

EVL plus Placebo

PLACEBO COMPARATOR

Emergency EVL plus placebo infusion for 5 days

Drug: Placebo

Interventions

Somatostatin DRUG

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

Also known as: Somatosan, Somastin

EVL plus Somatostatin

Placebo DRUG

Emergency EVL plus placebo infusion for 5 days

EVL plus Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of portal hypertension
• Having hematemesis and/or melena within 24 hour prior to admission
• Source of bleeding should be esophageal varices

You may not qualify if:

• 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.

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

Department of Gastroenterology, G B Pant Hospital

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

Location

Related Publications (1)

• Kumar A, Jha SK, Mittal VV, Sharma P, Sharma BC, Sarin SK. Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial. J Clin Exp Hepatol. 2015 Sep;5(3):204-12. doi: 10.1016/j.jceh.2015.06.001. Epub 2015 Jun 16.

  PMID: 26628838 DERIVED

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Shiv K Sarin, MD, DM

  G B Pant Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: November 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 28, 2010

Record last verified: 2010-12

Locations

IN (1)