Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

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.

• Sodium tetradecyl sulfate (Drug): Subjects receive sodium tetradecyl sulfate via balloon-occluded retrograde transvenous obliteration at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding.
• Cyanoacrylate (Drug): 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.

Primary outcomes

• recurrent gastric variceal bleeding [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]: recurrent gastric variceal bleeding after interventions
• further liver decompensation [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]: further liver decompensation after intervensions

Secondary outcomes

• recurrent upper gastrointestinal bleeding [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]: recurrent upper gastrointestinal bleeding after interventions
• mortality or liver transplantation [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]: mortality or liver transplantation after intervensions

Sex: All, ages: 20 Years to any

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

• Ryan BM, Stockbrugger RW, Ryan JM. A pathophysiologic, gastroenterologic, and radiologic approach to the management of gastric varices. Gastroenterology. 2004 Apr;126(4):1175-89. doi: 10.1053/j.gastro.2004.01.058. PMID 15057756
• Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607. PMID 1446890
• Rockey DC. Management of gastric varices. Gastroenterology. 2001 Jun;120(7):1875-6; discussion 1876-7. doi: 10.1053/s0016-5085(01)70197-7. No abstract available. PMID 11375970
• Tripathi D, Therapondos G, Jackson E, Redhead DN, Hayes PC. The role of the transjugular intrahepatic portosystemic stent shunt (TIPSS) in the management of bleeding gastric varices: clinical and haemodynamic correlations. Gut. 2002 Aug;51(2):270-4. doi: 10.1136/gut.51.2.270. PMID 12117893
• Park JK, Saab S, Kee ST, Busuttil RW, Kim HJ, Durazo F, Cho SK, Lee EW. Balloon-Occluded Retrograde Transvenous Obliteration (BRTO) for Treatment of Gastric Varices: Review and Meta-Analysis. Dig Dis Sci. 2015 Jun;60(6):1543-53. doi: 10.1007/s10620-014-3485-8. Epub 2014 Dec 18. PMID 25519690
• Tan PC, Hou MC, Lin HC, Liu TT, Lee FY, Chang FY, Lee SD. A randomized trial of endoscopic treatment of acute gastric variceal hemorrhage: N-butyl-2-cyanoacrylate injection versus band ligation. Hepatology. 2006 Apr;43(4):690-7. doi: 10.1002/hep.21145. PMID 16557539

• Wen-Chi Chen, M.D, Principal investigator, Kaohsiung Veterans General Hospital.