Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06881082

Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices

Led by Tanta University · Updated on 2025-03-18

320

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this randomized controlled trial is to evaluate the cross-section band ligation technique versus the stepladder band ligation technique in esophageal varices prophylaxis. Researchers will compare cross-section and step ladder band ligation techniques for esophageal varices prophylaxis regarding efficacy, side effects, variceal recurrence, and survival. Participants will undergo history-taking, clinical examination, laboratory investigations, and upper endoscopy. Index upper endoscopy will be performed to evaluate the presence, size, and grade of esophageal varices. Patients will be randomly assigned to endoscopic band ligation (EBL) either by cross-section or stepladder techniques every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3-6 months to check for variceal recurrence. For a period of 6 months, all patients in the treatment groups will be followed up every 3 months with clinic visits, including laboratory testing, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment.

CONDITIONS

Official Title

Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged >18 years
  • Cirrhotic patients
  • Endoscopic evidence of medium/large-sized esophageal varices
Not Eligible

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, and severe bradycardia
  • Patients with severe respiratory diseases (COPD, bronchial asthma)
  • Uncontrolled diabetes mellitus
  • Renal impairment
  • Hepatocellular carcinoma
  • Allergy to carvedilol
  • Pregnancy or lactation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tanta University Hospitals

Tanta, Gharbyea, Egypt, 31516

Actively Recruiting

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Research Team

R

Rania M Elkafoury, MD

CONTACT

N

Nabila A Elgazzar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NA

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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