Comparing carvedilol and endoscopic band ligation for preventing esophageal variceal bleeding
Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension
PHASE2; PHASE3 · Tanta University · NCT04499898
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 |
| Enrollment | 306 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Tanta) |
| Trial ID | NCT04499898 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown varying success with similar approaches, but this specific comparison of carvedilol and endoscopic band ligation is novel.
Eligibility criteria
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 this trial is running
Tanta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Varices