Comparing carvedilol and endoscopic band ligation for preventing esophageal variceal bleeding
Official title: Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension
Run by Tanta University · NCT04499898 · Data updated 2026-11-12
This study tests whether a medication called carvedilol works better than a procedure called endoscopic band ligation to prevent bleeding from swollen veins in the esophagus for patients with liver disease and high blood pressure.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 306 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Status | Recruiting |
| Started | October 1, 2018 |
| Main results expected | December 1, 2030 |
| Study ends | December 10, 2030 |
| Registry record updated | August 5, 2020 |
| Trial ID | NCT04499898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are cirrhotic patients over 18 years old with arterial hypertension and endoscopic evidence of medium to large-sized esophageal varices.
✕Probably not a fit
Patients with a history of variceal bleeding, advanced cardiovascular or respiratory diseases, or those on medications affecting portal pressure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of carvedilol compared to endoscopic band ligation in preventing esophageal variceal bleeding in cirrhotic patients who also have arterial hypertension. It is a randomized controlled trial that aims to determine which intervention is more effective for primary prophylaxis in this high-risk population. The study includes patients over 18 years old with medium to large-sized esophageal varices and excludes those with a history of variceal bleeding or other significant health issues.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for preventing life-threatening esophageal variceal bleeding in at-risk patients.
How similar studies have gone: Previous studies have shown varying success with similar approaches, but this specific comparison of carvedilol and endoscopic band ligation is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Sherief Abd-Elsalam
Tanta, Egypt Recruiting
Study contacts
- Principal investigator: Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect — Tanta University Faculty of medicine
- Study coordinator: Sherief Abd-Elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How long to fast after esophageal variceal ligation in cirrhosis
This trial tests whether starting oral intake 6 hours after EVL is safer and as effective as waiting 24 or 48 hours in adults with cirrhosis and esophageal varices.
-
Using TIPS to treat complicated portal hypertension in porto‑sinusoidal vascular disease
This research tries TIPS (a shunt placed in the liver) for people with porto‑sinusoidal vascular disease who have bleeding, refractory ascites, or portal vein thrombosis from portal hypertension.
-
2D-shear wave spleen elastography to detect clinically significant portal hypertension and high-risk esophageal varices
This study tests whether a 2D-shear wave spleen ultrasound can rule in or rule out clinically significant portal hypertension and high‑risk esophageal varices in adults with advanced chronic liver disease.
-
Improving treatment strategies for bleeding from esophageal varices in portal hypertension
This study is trying to find better ways to treat bleeding from swollen veins in the esophagus for people with portal hypertension by personalizing treatment based on their specific conditions.
-
Using fecal calprotectin to predict esophageal varices in cirrhotic patients
This study is testing if measuring a substance in stool can help predict if people with liver cirrhosis have esophageal varices and how serious they are.
-
Comparing two techniques for treating esophageal varices
This study is testing two different techniques for treating esophageal varices to see which one works better at preventing them from coming back.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.