Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

Study Overview
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Brief Summary
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This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Detailed Description
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In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Official Title
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RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide

Conditions
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Variceal Bleeding, Cirrhosis

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Somatostatin
* Drug: Octreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: liver cirrhosis age between 16 and 75 years Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment Patients whose systolic blood pressure <100 mmHg or pulse rate >100/min at the enrollment Patients who were not performed endoscopic or pharmacologic therapy for varices Signed informed consent Exclusion Criteria: Pregnancy Positive anti-HIV Ab A history of severe side-effects or contraindications to study drugs Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure >170 mmHg or diastolic pressure >100 mmHg) Chronic renal failure Hepatocellular carcinoma with protal vein thrombosis Coexisting malignancy except hepatocellular carcinoma

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terlipressin<br>treat with terlipressin IV for 5 days and endoscopic treatment | Drug: Terlipressin<br>* loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days<br>* Other names: Glypressin;|
| Active Comparator: Somatostatin<br>treat with somatostatin IV for 5 days and endoscopic treatment | Drug: Somatostatin<br>* loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days<br>* Other names: Somatosan;|
| Active Comparator: Octreotide<br>treat with octreotide IV for 5 days and endoscopic treatment | Drug: Octreotide<br>* loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days<br>* Other names: Sandostatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death) |  | 5 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects | at least one of the three criteria | 5 days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, Esophagus Disorders, Varicose Veins