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

Phase 4

Completed

• Conditions: Variceal Bleeding, Cirrhosis
• Interventions: Drug: Octreotide; Drug: Terlipressin; Drug: Somatostatin

• Registration Number: NCT00966355
• Lead Sponsor: Korea University

Brief Summary

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

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2013-04-23
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Results First Posted: 2018-03-19
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1034

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Octreotide	Octreotide	treat with octreotide IV for 5 days and endoscopic treatment
Terlipressin	Terlipressin	treat with terlipressin IV for 5 days and endoscopic treatment
Somatostatin	Somatostatin	treat with somatostatin IV for 5 days and endoscopic treatment

Primary Outcome Measures

Name	Time	Method
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)	5 days after enrollment

Secondary Outcome Measures

Name	Time	Method
Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects	5 days after enrollment	at least one of the three criteria

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of