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Recruiting NCT04499898

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

Phase II / Phase III Interventional Esophageal Varices

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carvedilol, Endoscopic band ligation.
Who it may be relevant to
Registry conditions: Esophageal Varices. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Carvedilol
    Carvedilol
  • Procedure Endoscopic band ligation
    Endoscopic band ligation

Primary outcome measures

  • Number of patients with the first variceal bleeding within 1 year [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Sherief Abd-Elsalam — Tanta

Identifiers

NCT: NCT04499898 · nabeela protocol

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗