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The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.
Gastric variceal bleeding is a severe condition associated with a high mortality. Bleeding from varices bleeding will be defined as the occurrence of hematemesis and/or melena requiring >2 U of blood or a decrease of 2 gm/dl of hemoglobin if no blood transfusion is given, with the confirmed endocopic visualization of GOV II and IGV I.
The beta blocker therapy is an effective method for the prevention of the first esophageal variceal bleeding; however, the efficacy in preventing first gastric variceal bleeding is controversial.
The investigators aimed to compare the efficacy in preventing the first gastric variceal bleeding in patients with documented GOV II and IGV I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-guided combined therapy | Experimental | Patients with endoscopic and EUS documented GOV II and IGV I will be included. Procedure will be performed under general anesthesia using a linear array therapeuthic echoendoscope, coils and cyanoacrylate will be injected within the feeder vessel under EUS and fluroscopic guidance. |
|
| Beta Blocker (Propranolol) | Placebo Comparator | o Beta-blocker (propranolol) will be started at dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose will be 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 will be attempted if cessation of the medication did not result in improvement of the reported side-effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coils + Cyanoacrylate Group + beta-blocker | Procedure | EUS-combined coiling and cyanoacrylate injection into the feeder vessel of GOV II and IGV I Patients with Gastric Varices GOV II or IGV I that have never bleed and are of high-risk GV according to Baveno VI consensus will be prophylactically obliterated via the EUS-guided coiling and cyanoacrylate injection. Patients will also be on beta-blocker therapy as indicated in the other group. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding rate secondary to gastric varices | Number of patients with melena or hematemesis accompanied by Hemoglobin drop > 2g/dL | 12 months |
| Mortality secondary to gastrointestinal bleeding | mortality rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reinterventions | number of endoscopic or endoscopic ultrasound procedures requiered for the management of gastri varices | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Robles-Medranda, M.D. | Contact | +593-042109180 | carlosoakm@yahoo.es | |
| Roberto Oleas, M.D. | Contact | +593-042109180 | robertoleas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Robles-Medranda, M.D. | Instituto Ecuatoriano de Enfermedades Digestivas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Ecuatoriano de Enfermedades Digestivas | Recruiting | Guayaquil | Guayas | 090505 | Ecuador |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21145834 | Result | Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5. |
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Randomized control trial, parallel location , 1:1 allocation
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Endoscopic performing EUS evaluation on follow-up will be masked to initial patient allocation
|
| beta blocker therapy | Drug | A beta-blocker (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. |
|
| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D005355 | Fibrosis |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| 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 |
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