Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04499898

Enrollment

306

Registered

2020-08-05

Start date

2018-10-01

Completion date

2030-12-10

Last updated

2020-08-05

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

Conditions

Esophageal Varices

Brief summary

Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Detailed description

A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Interventions

DRUGCarvedilol

Carvedilol

PROCEDUREEndoscopic band ligation

Endoscopic band ligation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* • Aged \>18 years * Cirrhotic patients with arterial hypertension * Endoscopic evidence of medium/large-sized esophageal varices

Exclusion criteria

* • History of variceal bleeding or previous primary prevention of varices. * Portal vein thrombosis or previous porto-systemic shunts as TIPS. * Patients on drugs affecting portal pressure (beta blockers, nitrates). * Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia. * Patients with severe respiratory diseases (COPD, bronchial asthma). * Uncontrolled diabetes mellitus * Renal impairment * Hepatocellular carcinoma * Allergy to carvedilol * Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with the first variceal bleeding within 1 year	1 year	The number of patients with the first variceal bleeding within 1 year

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, ass. prof.

sheriefabdelsalam@yahoo.com00201147773440

Backup ContactNabila el-gazzar, ass. lect.