Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices
Recruiting now · Not applicable
Conditions studied: Esophageal Varices
In brief
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.
Key facts
- Study ID
- NCT06881082
- Run by
- Tanta University
- People needed
- 320
- Starts
- 2024-12-01
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2025-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged >18 years.
- Cirrhotic patients.
- Endoscopic evidence of medium/large-sized esophageal varices.
You may not qualify if…
- 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.
Where it is running
- Tanta University Hospitals — Tanta, Gharbyea, Egypt (enrolling)
Full record on ClinicalTrials.gov
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