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The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Endoscopic Cyanoacrylate injection | Active Comparator | Endoscopic Cyanoacrylate injection in the gastric varix |
|
| 2. Beta-blocker | Placebo Comparator | Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Cyanoacrylate injection | Procedure | Endoscopic Cyanoacrylate injection in gastric varix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding from GV or death | Overall Study |
| Measure | Description | Time Frame |
|---|---|---|
| Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications. | Overall Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiv K Sarin, MD, DM | Director, G B Pant Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G B Pant Hospital | New Delhi | National Capital Territory of Delhi | 110002 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20551457 | Derived | Mishra SR, Chander Sharma B, Kumar A, Sarin SK. Endoscopic cyanoacrylate injection versus beta-blocker for secondary prophylaxis of gastric variceal bleed: a randomised controlled trial. Gut. 2010 Jun;59(6):729-35. doi: 10.1136/gut.2009.192039. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000269 | Adhesives |
| D000319 | Adrenergic beta-Antagonists |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| beta-blocker (propranolol) | Drug | Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect. |
|
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D045505 | Physiological Effects of Drugs |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |