Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Kaohsiung Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: Esophageal Varices

Treatments: Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT02740166

VGHKS13-CT6-06

Details and patient eligibility

About

Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.

Full description

Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.

Enrollment: 212 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of 20 to 80 years
• Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
• Stable hemodynamic condition for at least 3 days after banding ligation

Exclusion criteria

• Hepatocellular carcinoma or other malignancy
• Stroke or active sepsis
• Chronic kidney disease under renal replacement therapy
• Contraindications to non-selective beta-blockers
• A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
• Serum total bilirubin >10 mg/dL
• Grade III/IV hepatic encephalopathy
• Refractory ascites
• Hepato-renal syndrome
• Pregnancy
• Severe heart failure (NYHA Fc III/IV)
• Bronchial asthma or chronic obstructive pulmonary disease
• Second or third degree atrioventricular block
• Sick sinus syndrome
• Pacemaker use
• Severe hypotension
• Refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Banding ligation group

No Intervention group

Description:

Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.

Propranolol group

Experimental group

Description:

Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.

Treatment:

Drug: propranolol