Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding
Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension
1 other identifier
interventional
306
1 country
1
Brief Summary
Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 1, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 10, 2030
August 5, 2020
August 1, 2020
12.2 years
August 1, 2020
August 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
carvedilol
EXPERIMENTALCarvedilol
Band Ligation
ACTIVE COMPARATORBand Ligation
Interventions
Eligibility Criteria
You may qualify if:
- Aged \>18 years
- Cirrhotic patients with arterial hypertension
- Endoscopic evidence of medium/large-sized esophageal varices
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sherief Abd-Elsalam
Tanta, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Asem Elfert, Prof
Tanta University - Faculty of Medicine
- PRINCIPAL INVESTIGATOR
Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect
Tanta University Faculty of medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ass. Prof. Tropical Medicine
Study Record Dates
First Submitted
August 1, 2020
First Posted
August 5, 2020
Study Start
October 1, 2018
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 10, 2030
Last Updated
August 5, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share