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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

About this 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.

Eligibility criteria

Qualifiers

Aged >18 years.

Cirrhotic patients.

Endoscopic evidence of medium/large-sized esophageal varices.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • endoscopic band ligation with cross-section technique
  • Endoscopic band ligation using stepladder technique

Treatment groups

320 Participants
are divided into 2 treatment groups

Sponsors and collaborators