Esophageal Varices
Conditions
Keywords
Band ligation, esophageal varices prophylaxis
Brief summary
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.
Interventions
PROCEDUREendoscopic 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.
PROCEDUREEndoscopic 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
Sponsors
Tanta University
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vriceal bleeding rate at 6 weeks follow up | 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. |
| Mortality rate at 6 weeks follow up | 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. |
| Banding side effects at 6 weeks follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variceal obliteration rate at 6 months follow up | 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. |
| Variceal recurrence rate at 6 months follow up | 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. |
Countries
Egypt
Contacts
Primary ContactRania M Elkafoury, MD
Backup ContactNabila A Elgazzar, MD
Outcome results
None listed