Primary Prevention of Gastric Varices Bleed

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary prophylaxis of gastric varices is an important area of research, as gastric varices are a common complication of cirrhosis of the liver. Cirrhosis is a condition in which the liver becomes scarred and loses its ability to function properly, and it is a leading cause of morbidity and mortality worldwide. Gastric varices occur in up to 30% of patients with cirrhosis, and they can rupture, leading to life-threatening bleeding. The clinical, epidemiological, and public health context of primary prophylaxis of gastric varices is therefore the need to prevent the development of this complication in patients at risk for cirrhosis and to reduce the associated morbidity and mortality. The clinical trials on primary prophylaxis of gastric varices are therefore focused on evaluating the safety and efficacy of various interventions, such as beta-blockers and endoscopic techniques, in reducing the risk of gastric varices in patients with cirrhosis. The goal of this trial is to find the most effective and safe strategies for primary prophylaxis of gastric varices, in order to improve the outcomes for patients with cirrhosis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unity Health Toronto
• Treatments: Adrenergic beta-Antagonists; Propranolol

Criteria

Inclusion Criteria:

• Patients 18 years or older

• Referred to St. Michael's Hospital (SMH) for esophagogastroduodenoscopy (EGD) screening for varices

• Patients with GOV-2 or IGV-1 varices with the size ≥ 10 mm

Exclusion Criteria:

• Age >75 and < 18 years

• Pregnancy

• Contraindications to beta-blockers and cyanoacrylate injection

• Prior treatment for prevention of bleeding from patients on beta-blockers

• Hepatic encephalopathy grade III/IV

• Hepatorenal syndrome, hepatocellular carcinoma, presence of deep jaundice (serum bilirubin >170 mmol/L)

• Cardiorespiratory failure

• Co-existing large oesophageal varices which require endoscopic intervention

• Child-Pugh C (score of 10-15 indicating decompensated disease)

• Presence of serious complications of liver cirrhosis