Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

Study Overview
=================
Brief Summary
-----------------
The goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. The main questions it aims to answer are: Recurrent gastric variceal bleeding Further decompensation of liver cirrhosis Participants will receive balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. Researchers will compare balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection to see if the rebleeding rate associated with balloon-occluded retrograde transvenous obliteration is lower than that associated with endoscopic tissue glue injection.

Detailed Description
-----------------
Variceal bleeding is a severe complication of portal hypertension. Gastric variceal bleeding (GVB) is more severe than bleeding from esophageal varices. Gastric varices also have a higher risk of rebleeding than esophageal varices. Previous studies showed that endoscopic injection of cyanoacrylate was superior to endoscopic variceal ligation in the management of gastric variceal bleeding. Another study showed that transjugular intrahepatic portosystemic shunt had a lower rebleeding rate than endoscopic cyanoacrylate injection. However, transjugular intrahepatic portosystemic shunt (TIPS) is more invasive and carries a risk of development of hepatic encephalopathy and is usually preserved for uncontrolled variceal bleeding. Therefore, endoscopic cyanoacrylate injection is recommended as the treatment of choice for GVB. Balloon-occluded retrograde transvenous obliteration (BRTO) is a new therapy for gastric variceal bleeding. However, BRTO is associated with increased portal pressure and worsening of ascites, hepatohydrothorax, and esophageal varices. There are only a few retrospective studies comparing BRTO and endoscopic cyanoacrylate injection in the prevention of recurrent gastric variceal bleeding.

Official Title
-----------------
Balloon-occluded Retrograde Transvenous Obliteration Versus Endoscopic Tissue Glue Injection in the Prevention of Recurrent Gastric Variceal Bleeding

Conditions
-----------------
Gastric Varices Bleeding, Liver Decompensation

Intervention / Treatment
-----------------
* Drug: Sodium tetradecyl sulfate
* Drug: Cyanoacrylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 20 years a history of liver cirrhosis acute GOV2 or IGV1 bleeding Exclusion Criteria: previous treatment for gastric varices, including endoscopic therapy, transjugular intrahepatic portosystemic shunt, or shunt surgery hepatocellular carcinoma or other malignancy stroke, uremia, or active sepsis serum total bilirubin >10 mg/dL grade III/IV hepatic encephalopathy refractory ascites uncontrolled index bleeding pregnancy severe heart failure (NYHA Fc III/IV) allergy to cyanoacrylate, lipiodol, iodine, or sodium tetradecyl sulfate absence of gastrorenal shunt

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon-occluded retrograde transvenous obliteration<br>Information of drug: 3% sodium tetradecyl sulfate injection Name: Fibro-vein injection Manufacturer: STD Pharmaceutical Products Ltd. | Drug: Sodium tetradecyl sulfate<br>* Subjects receive sodium tetradecyl sulfate via balloon-occluded retrograde transvenous obliteration at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding.<br>|
| Active Comparator: Endoscopic cyanoacrylate injection<br>Information of drug: N-butyl-2-cyanoacrylate Name: Histoacryl blue Manufacturer: Braun, Melsungen, Germany | Drug: Cyanoacrylate<br>* Subjects receive endoscopic cyanoacrylate injection at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding then receive repeated endoscopic cyanoacrylate injection at 1-month intervals until obliteration of gastric varices.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent gastric variceal bleeding | recurrent gastric variceal bleeding after interventions | From date of randomization until the date of first documented recurrent gastric variceal bleeding or date of death from any cause, whichever comes first, assessed up to 100 months | 
| further liver decompensation | further liver decompensation after intervensions | From date of randomization until the date of first documented further liver decompensation or date of death from any cause, whichever comes first, assessed up to 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent upper gastrointestinal bleeding | recurrent upper gastrointestinal bleeding after interventions | From date of randomization until the date of first documented recurrent upper gastrointestinal bleeding or date of death from any cause, whichever comes first, assessed up to 100 months | 
| mortality or liver transplantation | mortality or liver transplantation after intervensions | From date of randomization until the date of documented liver transplantation or date of death from any cause, whichever comes first, assessed up to 100 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric varices bleeding, cyanoacrylate, balloon-occluded retrograde transvenous obliteration, liver decompensation, cirrhosis