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

Tanta University

Status: Enrolling

Conditions: Esophageal Varices

Treatments: Procedure: endoscopic band ligation with cross-section technique; Procedure: Endoscopic band ligation using stepladder technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06881082

36264PR978/12/24

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Double Blind

---

320 participants in 2 patient groups

cross-section band ligation

Experimental group

Description:

160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the cross-section band ligation technique.

Treatment:

Procedure: endoscopic band ligation with cross-section technique

stepladder band ligation

Active Comparator group

Description:

160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the step ladder band ligation technique.

Treatment:

Procedure: Endoscopic band ligation using stepladder technique