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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVL plus Somatostatin | Experimental | Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days |
|
| EVL plus Placebo | Placebo Comparator | Emergency EVL plus placebo infusion for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatostatin | Drug | Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Death during the same admission to the hospital | During the same admission |
| Transfusion requirement | Amount of packed cell or FFP infusions received during the hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiv K Sarin, MD, DM | G B Pant Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, G B Pant Hospital | New Delhi | National Capital Territory of Delhi | 110 002 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26628838 | Derived | 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. |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013004 | Somatostatin |
| ID | Term |
|---|---|
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Emergency EVL plus placebo infusion for 5 days |
|
| During hospital stay |
| ICU stay in days | Number of dys the patient spent in ICU | During the hospital stay |
| Drug-related adverse effects | Adverse effects due to somatostatin or placebo infusion | 5 days |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010187 | Pancreatic Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |