Liver Cirrhoses Clinical Trial
Official title:
Interventional Devascularization Plus HVPG‐Guided Carvedilol Therapy vs TIPS for the Prevention of Gastric Variceal Rebleeding in Patients With Liver Cirrhosis: A Prospective, Randomized, Controlled Trial
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.
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