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

Not Applicable

Recruiting

• Conditions: Esophageal Varices

• Registration Number: NCT06881082
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Banding side effects at 6 weeks follow up	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.
Vriceal bleeding rate at 6 weeks follow up	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.
Mortality rate at 6 weeks follow up	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.

Secondary Outcome Measures

Name	Time	Method
Variceal recurrence rate at 6 months follow up	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.
Variceal obliteration rate at 6 months follow up	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.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbyea, Egypt