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

Sherief Abd-Elsalam

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Esophageal Varices

Treatments: Drug: Carvedilol; Procedure: Endoscopic band ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT04499898

nabeela protocol

Details and patient eligibility

About

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

Full description

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

Enrollment: 306 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

carvedilol

Experimental group

Description:

Carvedilol

Treatment:

Drug: Carvedilol

Band Ligation

Active Comparator group

Description:

Band Ligation

Treatment:

Procedure: Endoscopic band ligation