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

Korea University

Status and phase: Completed; Phase 4

Conditions: Variceal Bleeding, Cirrhosis

Treatments: Drug: Octreotide; Drug: Somatostatin; Drug: Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT00966355

TPSTOT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,034 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,034 participants in 3 patient groups

Terlipressin

Active Comparator group

Description:

treat with terlipressin IV for 5 days and endoscopic treatment

Treatment:

Drug: Terlipressin

Somatostatin

Active Comparator group

Description:

treat with somatostatin IV for 5 days and endoscopic treatment

Treatment:

Drug: Somatostatin

Octreotide

Active Comparator group

Description:

treat with octreotide IV for 5 days and endoscopic treatment

Treatment:

Drug: Octreotide