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This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic band ligation | Active Comparator | Endoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment |
|
| Propranolol | Active Comparator | start with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) |
|
| EBL+Propranolol | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic band ligation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| First esophageal variceal bleeding | First esophageal variceal bleeding after enrollment | 3 years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events | Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events | 3 years after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soon Ho Um, Prof | Contact | 82-2-920-5019 | umsh@korea.ac.kr | |
| Yeon Seok Seo, MD | Contact | 82-2-920-6608 | drseo@korea.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Soon Ho Um, Prof | Korea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | 136-705 | South Korea |
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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 |
|---|---|
| D011433 | Propranolol |
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
|
| Propranolol | Drug |
|
|
|
| EBL+Propranolol | Procedure |
|
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |