Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Banding side effects at 6 weeks follow up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: endoscopic band ligation with cross-section technique (Procedure)
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.
Intervention: Endoscopic band ligation using stepladder technique (Procedure)
Outcomes
Primary Outcomes
Banding side effects at 6 weeks follow up
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.
Vriceal bleeding rate at 6 weeks follow up
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.
Mortality rate at 6 weeks follow up
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.
Secondary Outcomes
- Variceal recurrence rate at 6 months follow up(through study completion, an average of 1 year)
- Variceal obliteration rate at 6 months follow up(through study completion, an average of 1 year)
Investigators
Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Tanta University