Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices

Recruiting · NCT06881082 · Interventional (participants receive a specific treatment) · Lead sponsor: Tanta University

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Interventions studied

Endoscopic band ligation using stepladder techniqueendoscopic band ligation with cross-section technique

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

Tanta University Hospitals - Tanta, Gharbyea, Egypt

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →