Secondary Prophylaxis Gastric Variceal Bleed

Govind Ballabh Pant Hospital

Status: Completed

Conditions: Cirrhosis

Treatments: Procedure: Endoscopic Cyanoacrylate injection; Drug: beta-blocker (propranolol)

Study type: Interventional

Funder types: Other

Identifiers

NCT00888784

SRM03

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 2 patient groups, including a placebo group

1. Endoscopic Cyanoacrylate injection

Active Comparator group

Description:

Endoscopic Cyanoacrylate injection in the gastric varix

Treatment:

Procedure: Endoscopic Cyanoacrylate injection

2. Beta-blocker

Placebo Comparator group

Description:

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.

Treatment:

Drug: beta-blocker (propranolol)