Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Study Overview
=================
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.

Official Title
-----------------
Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices

Conditions
-----------------
Esophageal Varices

Intervention / Treatment
-----------------
* Drug: propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Banding ligation group<br>Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. | |
| Experimental: Propranolol group<br>Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. | Drug: propranolol<br>* Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent esophageal variceal bleeding | recurrent esophageal variceal bleeding after eradication of esophageal varices | 6 years | 
| mortality or liver transplantation | mortality or liver transplantation after eradication of esophageal varices | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects | adverse effects associated with non-selective beta-blockers and banding ligation | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Varices; propranolol; banding ligation