Cirrhosis
Conditions
Brief summary
The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.
Interventions
Endoscopic Cyanoacrylate injection in gastric varix
Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \>90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \<90 mm Hg or pulse rate \<55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included
Exclusion criteria
* Presence of esophageal varix * GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection * Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding from GV * Patients already on beta-blocker or nitrates * Undetermined origin of bleeding from esophageal varix or gastric varix * Hepatic encephalopathy grade III/IV * Hepatorenal syndrome * Hepatocellular carcinoma * Presence of deep jaundice (serum bilirubin \> 10 mg/dl) * Uremia * Cerebrovascular accident * Cardiorespiratory failure * Pregnancy or patients not giving informed consent for endoscopic procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rebleeding from GV or death | Overall Study |
Secondary
| Measure | Time frame |
|---|---|
| Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications. | Overall Study |
Countries
India