Actively Recruiting
Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension
Led by Sherief Abd-Elsalam · Updated on 2020-08-05
306
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial compares carvedilol, a medication, with endoscopic band ligation, a procedure, to prevent the first episode of bleeding from esophageal varices in patients who have liver cirrhosis and arterial hypertension. The study evaluates which method might better reduce the risk of variceal bleeding, a serious complication in these patients. It is a randomized controlled trial sponsored by Sherief Abd-Elsalam and includes adult participants aged 18 and older. Participants are randomly assigned to receive either carvedilol or undergo endoscopic band ligation. Carvedilol is given as a drug treatment, while endoscopic band ligation involves a procedure to tie off enlarged veins in the esophagus to prevent bleeding. The study monitors patients over a one-year period to compare the effects of these two approaches as primary prevention for variceal bleeding. During the study, participants will be assessed to see if they experience their first variceal bleeding within one year. Researchers will perform regular evaluations to monitor the patients' health and the condition of their esophageal varices. Safety and tolerability are also observed, with follow-up visits to track outcomes and any complications related to the treatments. The total participation time is at least one year based on the primary outcome measure.
CONDITIONS
Brief Title
Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged >18 years
- Cirrhotic patients with arterial hypertension
- Endoscopic evidence of medium or large-sized esophageal varices
You will not qualify if you...
- History of variceal bleeding or previous primary prevention of varices
- Portal vein thrombosis or previous porto-systemic shunts such 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 such as COPD or bronchial asthma
- Uncontrolled diabetes mellitus
- Renal impairment
- Hepatocellular carcinoma
- Allergy to carvedilol
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants receive either carvedilol medication or undergo endoscopic band ligation as primary prevention for esophageal variceal bleeding.
Trial Site Locations
Total: 1 location
1
Sherief Abd-Elsalam
Tanta, Egypt
Actively Recruiting
Research Team
S
Sherief Abd-Elsalam, ass. prof.
N
Nabila el-gazzar, ass. lect.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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