Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices
ConditionEsophageal Varices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged >18 years.
Cirrhotic patients.
Endoscopic evidence of medium/large-sized esophageal varices.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
endoscopic band ligation with cross-section technique
Procedure/SurgeryEndoscopic 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 using stepladder technique
Procedure/SurgeryEndoscopic 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
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: cross-section band ligationExperimental treatment 1 intervention
Group B: stepladder band ligationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Vriceal bleeding rate at 6 weeks follow up
-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 year2
Mortality rate at 6 weeks follow up
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 year3
Banding side effects at 6 weeks follow up
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 yearSecondary outcomes
1
Variceal obliteration rate at 6 months follow up
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 year2
Variceal recurrence rate at 6 months follow up
Recurrence of esophageal varices rate at 6 months after obliteration will be evaluated and compared across the studied groups.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov