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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cross-section band ligation | Experimental | 160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the cross-section band ligation technique. |
|
| stepladder band ligation | Active Comparator | 160 cirrhotic patients with endoscopic evidence of medium/large-sized esophageal varices undergoing endoscopic prophylaxis using the step ladder band ligation technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic band ligation with cross-section technique | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| 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. | through study completion, an average of 1 year |
| 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Variceal recurrence rate at 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania M Elkafoury, MD | Contact | +201004672358 | rania.elkafoury@med.tanta.edu.eg | |
| Nabila A Elgazzar, MD | Contact | 00201288585733 | nabilaelgazzar@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nabila A Elgazzar, MD | Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbyea | 31516 | Egypt |
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| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
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| Endoscopic band ligation using stepladder technique | Procedure | 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 |
|
Recurrence of esophageal varices rate at 6 months after obliteration will be evaluated and compared across the studied groups. |
| through study completion, an average of 1 year |
| D008107 | Liver Diseases |