Recruiting

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

ClinicalTrials.gov IDNCT06881082

PhaseNA

Enrollment320

SponsorTanta University

Age18 Years

SexALL

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Conditions studied

Esophageal Varices

About this study

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.

Interventions

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.
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

Primary outcomes

Vriceal bleeding rate at 6 weeks follow up (through study completion, an average of 1 year)
Mortality rate at 6 weeks follow up (through study completion, an average of 1 year)
Banding side effects at 6 weeks follow up (through study completion, an average of 1 year)

Eligibility information

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 locations

Tanta University Hospitals, Tanta, Gharbyea 31516 Egypt

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.