Status:

RECRUITING

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

Lead Sponsor:

Sherief Abd-Elsalam

Conditions:

Esophageal Varices

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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

Eligibility Criteria

Inclusion

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

Exclusion

  • • 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

Key Trial Info

Start Date :

October 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 10 2030

Estimated Enrollment :

306 Patients enrolled

Trial Details

Trial ID

NCT04499898

Start Date

October 1 2018

End Date

December 10 2030

Last Update

August 5 2020

Active Locations (1)

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1

Sherief Abd-Elsalam

Tanta, Egypt