A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding (AVB-EVL+S)
Primary Purpose
Acute Bleeding Esophageal Varices, Portal Hypertension, Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Somatostatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bleeding Esophageal Varices focused on measuring Variceal bleeding, Endoscopic therapy, Band ligation, Somatostatin, Vasoactive drugs, Octreotide
Eligibility 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.
Sites / Locations
- Department of Gastroenterology, G B Pant Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EVL plus Somatostatin
EVL plus Placebo
Arm Description
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
Emergency EVL plus placebo infusion for 5 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
In-hospital mortality
Death during the same admission to the hospital
Transfusion requirement
Amount of packed cell or FFP infusions received during the hospital stay
ICU stay in days
Number of dys the patient spent in ICU
Drug-related adverse effects
Adverse effects due to somatostatin or placebo infusion
Full Information
NCT ID
NCT01267669
First Posted
December 27, 2010
Last Updated
December 27, 2010
Sponsor
Govind Ballabh Pant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01267669
Brief Title
A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Govind Ballabh Pant Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bleeding Esophageal Varices, Portal Hypertension, Cirrhosis
Keywords
Variceal bleeding, Endoscopic therapy, Band ligation, Somatostatin, Vasoactive drugs, Octreotide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVL plus Somatostatin
Arm Type
Experimental
Arm Description
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
Arm Title
EVL plus Placebo
Arm Type
Placebo Comparator
Arm Description
Emergency EVL plus placebo infusion for 5 days
Intervention Type
Drug
Intervention Name(s)
Somatostatin
Other Intervention Name(s)
Somatosan, Somastin
Intervention Description
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Emergency EVL plus placebo infusion for 5 days
Primary Outcome Measure Information:
Title
Treatment failure
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
In-hospital mortality
Description
Death during the same admission to the hospital
Time Frame
During the same admission
Title
Transfusion requirement
Description
Amount of packed cell or FFP infusions received during the hospital stay
Time Frame
During hospital stay
Title
ICU stay in days
Description
Number of dys the patient spent in ICU
Time Frame
During the hospital stay
Title
Drug-related adverse effects
Description
Adverse effects due to somatostatin or placebo infusion
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv K Sarin, MD, DM
Organizational Affiliation
G B Pant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 002
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
26628838
Citation
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.
Results Reference
derived
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A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
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