Primary Prophylaxis of Gastric Variceal Bleed

Study Overview
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Brief Summary
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The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.

Official Title
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Primary Prophylaxis of Gastric Variceal Bleed: Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration

Conditions
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Gastric Varices

Intervention / Treatment
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* Procedure: Balloon-occluded retrograde transvenous obliteration
* Procedure: Endoscopic cyanoacrylate injection
* Drug: N-butyl-2-cyanoacrylate
* Drug: Lauromacrogol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhosis Patients with high risk gastric varices (GOV2 or IGV1) Presence of gastrorenal shunt Exclusion Criteria: Acute bleed or past history of bleed from gastric varices Previous treatment of gastric varices. Non-cirrhotic portal hypertension Contraindications to cyanoacrylate injection or BRTO Portal cavernoma Hepatorenal syndrome Proven malignancy including hepatocellular carcinoma End-stage renal disease under renal replacement therapy; Cardiorespiratory failure Pregnancy or patients not giving informed consent for endoscopic procedures

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BRTO<br>Balloon-occluded retrograde transvenous obliteration | Procedure: Balloon-occluded retrograde transvenous obliteration<br>* Balloon-occluded retrograde transvenous obliteration<br>Drug: Lauromacrogol<br> <br> |
| Active Comparator: NBCA<br>Endoscopic cyanoacrylate injection | Procedure: Endoscopic cyanoacrylate injection<br>* Endoscopic cyanoacrylate injection<br>Drug: N-butyl-2-cyanoacrylate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding rate from gastric varices |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of gastric varices |  | 3 years | 
| Number of participants with increase or decrease in the size of gastric varices |  | 3 years | 
| Number of participants with appearance or worsening of new oesophageal varices |  | 3 years | 
| Number of participants with appearance or worsening of portal hypertensive gastropathy |  | 3 years | 
| Number of participants with appearance or worsening of ascites |  | 3 years | 
| Number of participants with complication |  | 3 years | 
| Average in-hospital stay |  | 3 years | 
| Cost of treatment |  | 3 years | 
| Mortality rate |  | 3 years |