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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terlipressin | Active Comparator | treat with terlipressin IV for 5 days and endoscopic treatment |
|
| Somatostatin | Active Comparator | treat with somatostatin IV for 5 days and endoscopic treatment |
|
| Octreotide | Active Comparator | treat with octreotide IV for 5 days and endoscopic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death) | 5 days after enrollment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soon Ho Um, Prof | Korea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
failure to fulfill inclusion criteria, no cirrhosis, prior endoscopic therapy within 2 weeks, enrolled within 6 weeks before index bleed, severe cardiovascular diseases, chronic renal failure, hepatocellular carcinoma invading portal vein, other malignancy, pregnancy, HIV-positive, hypersensitivity to the study drugs, or refusal to participate.
Patients with liver cirrhosis presenting with either hematemesis or melena between October 1, 2006 and May 31, 2010 at eleven medical centers distributed throughout Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Octreotide | treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days |
| FG001 | Somatostatin | treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days |
| FG002 | Terlipressin | treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Octreotide | treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days |
| BG001 | Somatostatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death) | Posted | Number | participants | 5 days after enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Octreotide | treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Diarrhea developed in 2 patients. Both patients were included in the octreotide group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Soon Ho Um | Korea University College of Medicine | +82-2-920-5019 | umsh@korea.ac.kr |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D004935 | Esophageal Diseases |
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| D013004 | Somatostatin |
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| Somatostatin | Drug | loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days |
|
|
| Octreotide | Drug | loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days |
|
|
| Lost to Follow-up |
|
treat with somatostatin IV for 5 days and endoscopic treatment
Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
| BG002 | Terlipressin | treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
treat with terlipressin IV for 5 days and endoscopic treatment
Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
|
|
| Secondary | Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects | at least one of the three criteria | Posted | Number | participants | 5 days after enrollment |
|
|
|
| 0 |
| 260 |
| 3 |
| 260 |
| EG001 | Somatostatin | treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days | 0 | 259 | 3 | 259 |
| EG002 | Terlipressin | treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days | 0 | 261 | 4 | 261 |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D010187 | Pancreatic Hormones |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |