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

Phase 2

Recruiting

• Conditions: Esophageal Varices
• Interventions: Procedure: Endoscopic band ligation; Drug: Carvedilol

• Registration Number: NCT04499898
• Lead Sponsor: Sherief Abd-Elsalam

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

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-01
• Study First Submitted QC: 2020-08-01
• Last Update Submitted: 2020-08-01
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• • Aged >18 years

  • Cirrhotic patients with arterial hypertension
  • Endoscopic evidence of medium/large-sized esophageal varices

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Band Ligation	Endoscopic band ligation	Band Ligation
carvedilol	Carvedilol	Carvedilol

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt