NCT Number: NCT06881082
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Tanta, Gharbyea, 31516, Egypt
Location status: Recruiting
Amal M Dwidar, MD
SUB_INVESTIGATOR
Assem A Elfert, MD
PRINCIPAL_INVESTIGATOR
Dina H Ziada, MD
CONTACT
Eslam S Ismaiel, MD
SUB_INVESTIGATOR
Nabila A Elgazzar, MD
PRINCIPAL_INVESTIGATOR
Rania M Elkafoury, MD
SUB_INVESTIGATOR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: through study completion, an average of 1 year
-The occurrence of first variceal bleeding (early bleeding within 3 - 10 days after band ligation and late bleeding after that) will be evaluated and compared across the studied groups.
Time frame: through study completion, an average of 1 year
Bleeding-related mortality rate and overall mortality rate at 6 weeks will be assessed and compared across the studied groups.
Time frame: through study completion, an average of 1 year
Side effects of banding (e.g. post banding ulcers, portal hypertensive gastropathy, esophageal strictures and perforation) at 6 weeks will be evaluated and compared across the studied groups.
Time frame: through study completion, an average of 1 year
Obliteration of esophageal varices rate at 6 months will be evaluated and compared across the studied groups.
Time frame: through study completion, an average of 1 year
Recurrence of esophageal varices rate at 6 months after obliteration will be evaluated and compared across the studied groups.
Contact information is provided by the study sponsor or research team.
Nabila A Elgazzar, MD
CONTACT
Rania M Elkafoury, MD
CONTACT
Tanta University
Other
Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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