Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices
NCT ID: NCT06881082
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
320 participants
INTERVENTIONAL
2024-12-01
2025-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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.
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.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* Cirrhotic patients.
* Endoscopic evidence of medium/large-sized esophageal varices.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Principal Investigators
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Nabila A Elgazzar, MD
Role: PRINCIPAL_INVESTIGATOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Locations
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Tanta University Hospitals
Tanta, Gharbyea, Egypt
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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36264PR978/12/24
Identifier Type: -
Identifier Source: org_study_id
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