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

Korea University1,034 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,034

Conditions

Variceal Bleeding, Cirrhosis

Interventions

TerlipressinDRUG

loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days

SomatostatinDRUG

loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days

OctreotideDRUG

loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)

Time frame: 5 days after enrollment

Secondary Outcomes

Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects

at least one of the three criteria

Time frame: 5 days after enrollment

Data from ClinicalTrials.gov

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