Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02740166

Enrollment

212

Registered

2016-04-15

Start date

2013-06-30

Completion date

Unknown

Last updated

2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Varices

Keywords

Esophageal Varices; propranolol; banding ligation

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.

Interventions

DRUGpropranolol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Taiwan

Contacts

Primary ContactWen-Chi Chen, MD

wcchen@vghks.gov.tw886-7-3422121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026