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NCT Number: NCT06881082

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

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.

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Key information

Conditions

Esophageal Varices Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged >18 years.
  • Cirrhotic patients.
  • 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, and severe bradycardia.
  • Patients with severe respiratory diseases (COPD, bronchial asthma).
  • Uncontrolled diabetes mellitus.
  • Renal impairment.
  • Hepatocellular carcinoma.
  • Allergy to carvedilol.
  • Pregnancy or lactation.

Treatment and study plan

endoscopic band ligation with cross-section technique

Procedure

Endoscopic band ligation (EBL) of medium/large-sized esophageal varices using the cross-section banding technique. EBL will be repeated every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3- 6 months to check for variceal recurrence, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment.

Endoscopic band ligation using stepladder technique

Procedure

Endoscopic band ligation (EBL) of medium/large-sized esophageal varices using the stepladder banding technique. EBL will be repeated every two to four weeks until eradication. After eradication of varices, endoscopy will be repeated after 3- 6 months to check for variceal recurrence, evaluation of treatment-related side effects, bleeding rates, and mortality from EBL treatment

Primary outcomes

  1. Vriceal bleeding rate at 6 weeks follow up

    Time frame: through study completion, an average of 1 year

    -The occurrence of first variceal bleeding (early bleeding within 3 - 10 days after band ligation and late bleeding after that) will be evaluated and compared across the studied groups.

  2. Mortality rate at 6 weeks follow up

    Time frame: through study completion, an average of 1 year

    Bleeding-related mortality rate and overall mortality rate at 6 weeks will be assessed and compared across the studied groups.

  3. Banding side effects at 6 weeks follow up

    Time frame: through study completion, an average of 1 year

    Side effects of banding (e.g. post banding ulcers, portal hypertensive gastropathy, esophageal strictures and perforation) at 6 weeks will be evaluated and compared across the studied groups.

Secondary outcomes

  1. Variceal obliteration rate at 6 months follow up

    Time frame: through study completion, an average of 1 year

    Obliteration of esophageal varices rate at 6 months will be evaluated and compared across the studied groups.

  2. Variceal recurrence rate at 6 months follow up

    Time frame: through study completion, an average of 1 year

    Recurrence of esophageal varices rate at 6 months after obliteration will be evaluated and compared across the studied groups.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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