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RECRUITINGINTERVENTIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged \>18 years. - Cirrhotic patients. - Endoscopic evidence of medium/large-sized esophageal varices. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (1)

Tanta University Hospitals
Tanta, Gharbyea, Egypt