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Search / Trial NCT04499898

Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

Launched by SHERIEF ABD-ELSALAM · Aug 1, 2020

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is comparing two different methods to help prevent bleeding from enlarged veins in the esophagus, a condition known as esophageal varices, in patients who have liver cirrhosis and high blood pressure. The study is looking at whether a medication called carvedilol or a procedure called endoscopic band ligation is more effective at keeping these veins from bleeding. Patients eligible for the trial must be over 18 years old, have cirrhosis, and show signs of medium to large esophageal varices, but they cannot have a history of bleeding from these veins or certain other serious health conditions.

If you or a family member decide to participate, you can expect to be monitored closely throughout the study to see how well the chosen treatment works and if there are any side effects. The trial is currently recruiting participants and is open to all genders. It's important to discuss with your doctor to see if this study is a good fit, especially if there are any other health issues or medications involved. This research aims to find the best way to manage the risk of bleeding in patients with this serious condition.

Gender

ALL

Eligibility 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

About Sherief Abd Elsalam

Sherief Abd-elsalam is a dedicated clinical trial sponsor with extensive expertise in advancing medical research and innovation. Committed to improving patient outcomes, Abd-elsalam oversees the design, implementation, and management of clinical trials across various therapeutic areas. With a strong focus on regulatory compliance and ethical standards, he fosters collaboration between research institutions, healthcare professionals, and regulatory bodies to ensure the successful progression of trials. Abd-elsalam's leadership is characterized by a commitment to scientific integrity and a passion for translating research findings into actionable healthcare solutions.

Locations

Tanta, , Egypt

Patients applied

0 patients applied

Trial Officials

Asem Elfert, Prof

Study Director

Tanta University - Faculty of Medicine

Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect

Principal Investigator

Tanta University Faculty of medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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