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

Cirrhosis Clinical Trial

— AVB-EVL+S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267669
• Other study ID #: 2005-PHT-01
• Status: Completed
• Phase: N/A
• First received: December 27, 2010
• Last updated: December 27, 2010
• Start date: November 2005
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: Govind Ballabh Pant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bleeding Esophageal Varices
• Cirrhosis
• Esophageal and Gastric Varices
• Gastrointestinal Hemorrhage
• Hemorrhage
• Hypertension, Portal
• Portal Hypertension

Intervention

Drug:
• Somatostatin
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
• Placebo
Emergency EVL plus placebo infusion for 5 days

Locations

Country	Name	City	State
India	Department of Gastroenterology, G B Pant Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	In-hospital mortality	Death during the same admission to the hospital	During the same admission	No
Secondary	Transfusion requirement	Amount of packed cell or FFP infusions received during the hospital stay	During hospital stay	No
Secondary	ICU stay in days	Number of dys the patient spent in ICU	During the hospital stay	No
Secondary	Drug-related adverse effects	Adverse effects due to somatostatin or placebo infusion	5 days	Yes