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

Variceal Bleeding, Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966355
• Other study ID #: TPSTOT
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2009
• Last updated: August 22, 2017
• Start date: September 2006
• Est. completion date: May 2010

Study information

• Verified date: August 2017
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1034
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hemorrhage
• Variceal Bleeding, Cirrhosis

Intervention

Drug:
• Terlipressin
loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
• Somatostatin
loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
• Octreotide
loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)		5 days after enrollment
Secondary	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