Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 and up

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

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment306 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta)
StatusRecruiting
StartedOctober 1, 2018
Main results expectedDecember 1, 2030
Study endsDecember 10, 2030
Registry record updatedAugust 5, 2020
Trial IDNCT04499898 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.