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

March 11, 2025 updated by: Rania Mamdouh Elkafoury, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Gharbyea
      • Tanta, Gharbyea, Egypt, 31516
        • Recruiting
        • Tanta University Hospitals
        • Contact:
        • Contact:
          • Amal M Dwidar, MD
        • Contact:
          • Rania M Elkafoury, MD
        • Contact:
          • Nabila A Elgazzar, MD
        • Contact:
        • Contact:
          • Eslam S Ismaiel, MD
        • Contact:
          • Assem A Elfert, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cross-section band ligation
160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the cross-section band ligation technique.
Procedure: endoscopic band ligation with cross-section technique
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.
Active Comparator: stepladder band ligation
160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the step ladder band ligation technique.
Procedure: Endoscopic band ligation using stepladder technique
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Nabila A Elgazzar, MD, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR978/12/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Varices

Clinical Trials on endoscopic band ligation with cross-section technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe