Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged \>18 years.

• Cirrhotic patients.

• Endoscopic evidence of medium/large-sized esophageal varices.

Locations
Other Locations
Egypt
Tanta University Hospitals
RECRUITING
Tanta
Contact Information
Primary
Rania M Elkafoury, MD
rania.elkafoury@med.tanta.edu.eg
+201004672358
Backup
Nabila A Elgazzar, MD
nabilaelgazzar@med.tanta.edu.eg
00201288585733
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 320
Treatments
Experimental: cross-section band ligation
160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the cross-section band ligation technique.
Active_comparator: stepladder band ligation
160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the step ladder band ligation technique.
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov