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NCT04499898 Clinical Trial

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

Esophageal Varices Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04499898
Other study ID # nabeela protocol
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 1, 2018
Est. completion date December 10, 2030

Study information
Verified date August 2020
Source Tanta University
Contact Sherief Abd-Elsalam, ass. prof.
Phone 00201147773440
Email sheriefabdelsalam@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 306
Est. completion date December 10, 2030
Est. primary completion date December 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Sherief Abd-Elsalam Tanta

Sponsors (1)
Lead Sponsor Collaborator
Sherief Abd-Elsalam

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with the first variceal bleeding within 1 year The number of patients with the first variceal bleeding within 1 year 1 year
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