Actively Recruiting
Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease A Randomized Controlled Trial
Led by Tanta University · Updated on 2025-03-18
320
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different techniques of endoscopic band ligation, the cross-section and stepladder methods, for preventing esophageal varices in patients with cirrhosis who have medium to large varices. This randomized controlled trial aims to compare these techniques by looking at their effectiveness, side effects, variceal recurrence, and survival rates. The study is sponsored by Tanta University and involves adult participants aged 18 and older with liver cirrhosis and confirmed esophageal varices. Participants will be randomly assigned to receive endoscopic band ligation using either the cross-section technique or the stepladder technique. Treatment sessions will take place every two to four weeks until the varices are eradicated. After eradication, follow-up endoscopies will be performed between 3 to 6 months to check for recurrence of varices. The study includes a follow-up period of 6 months with clinic visits every 3 months to assess side effects, bleeding rates, and mortality related to the band ligation treatments. During the study, participants will undergo initial assessments including medical history, clinical examination, laboratory tests, and upper endoscopy to determine variceal status. Regular monitoring visits will include laboratory testing and evaluation for treatment side effects and complications. The primary outcomes measured are variceal bleeding rate, mortality rate, and banding side effects at 6 weeks, with secondary outcomes including variceal obliteration and recurrence at 6 months. The total study duration is approximately one year, with careful observation to evaluate the comparative benefits and risks of each ligation method.
CONDITIONS
Brief Title
Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged >18 years
- Cirrhotic patients
- Endoscopic evidence of medium or large-sized esophageal varices
You will not qualify if you...
- History of variceal bleeding or previous primary prevention of varices
- Portal vein thrombosis or previous porto-systemic shunts like TIPS
- Current use of drugs affecting portal pressure such as beta blockers or nitrates
- Advanced cardiovascular diseases including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, and severe bradycardia
- Severe respiratory diseases such as COPD or bronchial asthma
- Uncontrolled diabetes mellitus
- Renal impairment
- Hepatocellular carcinoma
- Allergy to carvedilol
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated every 2 to 4 weeks until eradication
Participants undergo endoscopic band ligation using either the cross-section or stepladder technique. The band ligation is repeated every two to four weeks until the varices are eradicated.
Multiple visits every 2 to 4 weeks until variceal eradication
Duration - 3 to 6 months after eradication
After eradication of varices, participants have repeat endoscopy after 3 to 6 months to check for variceal recurrence, evaluate treatment-related side effects, bleeding rates, and mortality.
1 to 2 visits for follow-up endoscopy and assessments
Trial Site Locations
Total: 1 location
1
Tanta University Hospitals
Tanta, Gharbyea, Egypt, 31516
Actively Recruiting
Research Team
R
Rania M Elkafoury, MD
N
Nabila A Elgazzar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NA
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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