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

NCT06881082 | Recruiting

• 1 other identifier: 36264PR978/12/24
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Esophageal Varices

Keywords

Band ligation; esophageal varices prophylaxis

Outcome Measures

Primary Outcomes (3)

• Vriceal bleeding rate at 6 weeks follow up

  -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

  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

  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 Outcomes (2)

• Variceal obliteration rate at 6 months follow up

  through study completion, an average of 1 year

• Variceal recurrence rate at 6 months follow up

  through study completion, an average of 1 year

Study Arms (2)

cross-section band ligation

EXPERIMENTAL

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

stepladder band ligation

ACTIVE COMPARATOR

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

Interventions

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.

cross-section band ligation

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

stepladder band ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>18 years.
• Cirrhotic patients.
• Endoscopic evidence of medium/large-sized esophageal varices.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Study Officials

• Nabila A Elgazzar, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Nabila A Elgazzar, MD

CONTACT

00201288585733; nabilaelgazzar@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 18, 2025
• Study Start: December 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

EG (1)