Primary Prophylaxis of Gastric Varix Bleed

Study Overview
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Brief Summary
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In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.

Detailed Description
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Patients are followed up every 3 months or at the time of end point or complications.

Official Title
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A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed

Conditions
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Cirrhosis

Intervention / Treatment
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* Procedure: Endoscopic cyanoacrylate injection
* Drug: Beta-blocker (propranolol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included. Exclusion Criteria: Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection. Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV Patients already on beta-blocker or nitrates Undetermined origin of bleeding from esophageal varix or gastric varix Hepatic encephalopathy grade III/IV Hepatorenal syndrome Hepatocellular carcinoma Presence of deep jaundice (serum bilirubin > 10 mg/dl) Uremia Cerebrovascular accident Cardiorespiratory failure Pregnancy and patients not giving informed consent for endoscopic procedures

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic Cyanoacrylate injection<br>Endoscopic injection of cyanoacrylate in the gastric varix until obturation | Procedure: Endoscopic cyanoacrylate injection<br>* Endoscopic cyanoacrylate injection in gastric varix<br>* Other names: Glue injection in gastric varix;|
| No Intervention: No Intervention<br>No treatment offered for gastric varix | |
| Other: Beta-blocker (propranolol)<br>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. | Drug: Beta-blocker (propranolol)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding from gastric varix or death |  | Within 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications |  | Within 2 years |