NCT06881082Recruiting
Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices
Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease. A Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 4 Mar 2025
- Start date
- 1 Dec 2024
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Tanta University
- NCT number
- NCT06881082
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 1 Dec 2024 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
- Allergy to carvedilol.
Other
- Hepatocellular carcinoma.
- Pregnancy or lactation.
Who the study is looking for
- Aged \>18 years.
- Cirrhotic patients.
- Endoscopic evidence of medium/large-sized esophageal varices.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta University Hospitals Coordinator of this site? Confirm its status | Tanta | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.