Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS
Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS
Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV
 accounts for 10-20% of all variceal bleeding. For the prevention of gastric variceal
 bleeding, TIPS or BRTO as firstline treatments were suggested.

 No randomized trials have compared BRTO with other therapies. BRTO and its variations might
 increase portal pressure and might worsen complications, such as ascites or bleeding from EV.
 In this regard, if NSBB is combined with BRTO and its variations (we called interventional
 devascularization) for those HVPG responders, the drawbacks of interventional
 devascularization might be overcome. Therefore, the investigators conducted this RCT to
 compare the effectiveness and safety of TIPS with those of interventional devascularization
 in the prevention of rebleeding from gastric varices.
Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV
 accounts for 10-20% of all variceal bleeding. GV are classified according to their location
 in the stomach and their relationship with esophageal varices (EV). Accordingly, GV are
 divided into gastroesophageal varices (GOV) and isolated gastric varices (IGV) . The
 management of type 1 GOV, which extend from the esophagus along the lesser curvature of the
 stomach, is similar to the management of EV. Historically, bleeding from type 2 GOV (i.e. GOV
 extending into the fundus), type 1 IGV (i.e. located in the fundus) and type 2 IGV (i.e.
 located anywhere in the stomach), is considered to be more severe and difficult to treat than
 EV bleeding. Few studies, mostly retrospective and uncontrolled, have focused on the
 management of non-GOV1 GV, and the optimal treatment remains controversial.

 For the prevention of gastric variceal bleeding, treatment principles can be classified into
 two categories: decreasing portal pressure and obstructing GEV. Methods for decreasing portal
 pressure include medications (NSBB), radiological intervention (TIPS) and surgery. In
 contrast, methods for treating the obstruction of GEV include endoscopic approaches (EVL,
 EIS) or radiological intervention (such as BRTO). Recent portal hypertensive bleeding
 suggested TIPS or BRTO as firstline treatments in the prevention of rebleeding.

 BRTO is a procedure for treatment of fundal varices associated with a large
 gastro-/splenorenal collateral. The technique involves retrograde cannulation of the left
 renal vein by the jugular or femoral vein, followed by balloon occlusion and slow infusion of
 sclerosant to obliterate the gastro-/splenorenal collateral and fundal varices. Several
 variations of the technique exist, such as balloon-occluded antegrade transvenous
 obliteration or occlusion of the collateral by the placement of a vascular plug or coils.
 BRTO has the theoretical advantage over TIPS that it does not divert portal blood inflow from
 the liver. On the other hand, BRTO and its variations might increase portal pressure and
 might worsen complications, such as ascites or bleeding from EV. In this regard, if NSBB is
 combined with BRTO and its variations (we called interventional devascularization) for those
 HVPG responders, the drawbacks of interventional devascularization might be overcome.

 Therefore, the investigators conducted this RCT to compare the effectiveness and safety of
 TIPS with those of interventional devascularization in the prevention of rebleeding from
 gastric varices.
Inclusion Criteria:

 -  Liver cirrhosis diagnosed by clinical examination, imaging or biopsy

 -  Patients with a previous history of variceal hemorrhage

 -  Gastric variceal confirmed by an endoscopic examination, including IGV1 or IGV2

 -  Aged 18 to 75 years

 -  Adequate liver and kidney function, including Child-Turcotte-Pugh score < 12, MELD
 score <19, and serum creatinine less than 2 times the upper limit of normal.

 Exclusion Criteria:

 -  Active variceal bleeding

 -  Esophageal variceal, including GOV1 or GOV2 type, mainly esophageal varices;

 -  Refractory ascites

 -  Patients with contraindication to treatment of TIPS, including congestive heart
 failure, NYHA III and IV, pulmonary arterial hypertension(>50mmHg), polycystic liver,
 intrahepatic duct dilatation, spontaneous bacterial peritonitis, hepatic
 encephalopathy

 -  Patients with contraindication to treatment of Carvedilol, including asthma,
 insulin-dependent diabetes, peripheral vascular diseases

 -  Child-Turcotte-Pugh score >=12, or MELD score >=19

 -  Budd-Chiari syndrome

 -  The main portal vein thrombosis is greater than 50%

 -  Malignancies

 -  An uncontrolled infection

 -  Previously treated with TIPS, splenectomy pericardia vascular disconnection, or
 surgical shunts

 -  HIV or HIV related illness

 -  Allergic to contrast agent

 -  Lactating or pregnant

 -  Non-compliant patients