Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Phase 4

• Conditions: Esophageal Varices
• Interventions: Drug: propranolol

• Registration Number: NCT02740166
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2016-04
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Last Update Submitted: 2016-04-12
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol group	propranolol	Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.

Primary Outcome Measures

Name	Time	Method
recurrent esophageal variceal bleeding	6 years	recurrent esophageal variceal bleeding after eradication of esophageal varices
mortality or liver transplantation	6 years	mortality or liver transplantation after eradication of esophageal varices

Secondary Outcome Measures

Name	Time	Method
adverse effects	6 years	adverse effects associated with non-selective beta-blockers and banding ligation

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan