Secondary Prophylaxis Gastric Variceal Bleed

Govind Ballabh Pant Hospital64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cirrhosis

Interventions

Endoscopic Cyanoacrylate injectionPROCEDURE

Endoscopic Cyanoacrylate injection in gastric varix

beta-blocker (propranolol)DRUG

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

G B Pant Hospital

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Rebleeding from GV or death

Time frame: Overall Study

Secondary Outcomes

Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.

Time frame: Overall Study

Data from ClinicalTrials.gov

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