Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding
Condition: Esophageal and Gastric Varices
MeSH terms: Esophageal and Gastric Varices
Study type: Interventional
Phase: Phase 4

Summary: 
      Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal
      bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective
      β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is
      not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to
      gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.
    

Detailed description: 
      Gastric variceal bleeding is a lethal complication of portal hypertension. The rebleeding
      rate ranged between 30% to 50% in patients after initial hemostasis. Endoscopic cyanoacrylate
      injection is currently the choice of endoscopic therapy of acute gastric variceal bleeding
      and prevention of recurrent bleeding. However, the rebleeding rate is still high in the
      patients undergoing repeated endoscopic cyanoacrylate injection.

      Non-selective β-blockers are frequently used for the secondary prophylaxis of variceal
      bleeding. In the case of esophageal varices, combination of non-selective β-blockers and
      endoscopic therapy significantly lowers the rebleeding rate compared with endoscopic therapy
      alone. However, propranolol failed to decrease the rebleeding rate as an adjunct to
      endoscopic cyanoacrylate injection and was associated with a higher incidence of adverse
      effects in gastric variceal bleeding patients. A more potent non-selective β-blocker than
      propranolol might further decrease portal pressure and decrease the rebleeding rate.

      Carvedilol is a potent non-selective β-blocker with both beta and alpha-1 blocker effect. It
      significantly lowers portal pressure even in propranolol non-responders. However, it is
      unclear weather carvedilol will play a role in the prevention of recurrent gastric variceal
      bleeding. The investigators conducted a randomized controlled trial to compare the efficacy
      of carvedilol combined with endoscopic cyanoacrylate injection with endoscopic cyanoacrylate
      injection alone in secondary prophylaxis of gastric variceal bleeding.
    

Intervention name(s): carvedilol; cyanoacrylate
Intervention type(s): Drug; Drug
Intervention description(s): Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.; The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric varices; cyanoacrylate; carvedilol