RecruitingNot ApplicableNCT06881082

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

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


Sponsor

Tanta University

Enrollment

320 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two techniques for banding (treating) enlarged veins in the esophagus (called esophageal varices) in people with liver cirrhosis. These swollen veins can rupture and cause life-threatening bleeding. The two banding patterns — cross-section and stepladder — are compared for effectiveness and safety at preventing bleeding. **You may be eligible if:** - You are over 18 years old - You have cirrhosis (scarring of the liver) - You have medium or large esophageal varices confirmed by endoscopy - You have not had a variceal bleed before (this is for prevention) **You may NOT be eligible if:** - You have already had a variceal bleed or previous banding treatment - You have a blood clot in the portal vein or a prior surgical shunt (TIPS) - You are currently taking medications that lower portal vein pressure (like beta-blockers or nitrates) - You have advanced heart disease, kidney failure, or liver cancer - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREendoscopic 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.

PROCEDUREEndoscopic 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


Locations(1)

Tanta University Hospitals

Tanta, Gharbyea, Egypt

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NCT06881082


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