Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

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 management of acute gastric bleeding.

Official Title
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Comparison of Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration in the Management of Acute Gastric Variceal Bleeding

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 Active bleeding from gastric varices (GOV2 or IGV1) Presence of gastrorenal shunt Exclusion Criteria: Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding Previous use of TIPS or surgical shunt 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 |
| --- | --- | --- |
| The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | 3 years | 
| 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 |